Who is sponsoring NCT00719888?

NCT00719888 is sponsored by Fred Hutchinson Cancer Center.

What drugs are being tested in NCT00719888?

Interventions in NCT00719888: Cyclophosphamide, Cyclosporine, Double-Unit Umbilical Cord Blood Transplantation, Fludarabine, Laboratory Biomarker Analysis, Mycophenolate Mofetil, Total-Body Irradiation, Umbilical Cord Blood Transplantation, Thiotepa.

What condition does NCT00719888 study?

NCT00719888 studies Acute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Burkitt Lymphoma, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Follicular Lymphoma, Lymphoblastic Lymphoma, Lymphoplasmacytic Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Myelodysplastic Syndrome, Myelofibrosis, Non-Hodgkin Lymphoma, Plasma Cell Myeloma, Prolymphocytic Leukemia, Refractory Anemia, Small Lymphocytic Lymphoma.

Is NCT00719888 still recruiting?

NCT00719888 is currently completed. Last updated 7 March 2025.

Are results published for NCT00719888?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-03-07 · How we verify

NCT00719888

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease

Completed Phase 2 Results posted Last updated 7 March 2025

What this trial tests

Phase 2 trial testing Cyclophosphamide in Acute Biphenotypic Leukemia in 135 participants. Completed in 19 December 2024.

Timeline

18 November 2005

Primary endpoint
22 December 2023

19 December 2024

Quick facts

Lead sponsor	Fred Hutchinson Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	135
Start date	18 November 2005
Primary completion	22 December 2023
Estimated completion	19 December 2024
Sites	3 locations across United States

Drugs / interventions tested

Cyclophosphamide (cyclophosphamide) — full drug profile →
Cyclosporine (cyclosporine) — full drug profile →
Double-Unit Umbilical Cord Blood Transplantation
Fludarabine (FLUDARABINE) — full drug profile →
Laboratory Biomarker Analysis
Mycophenolate Mofetil (MYCOPHENOLATE MOFETIL) — full drug profile →
Total-Body Irradiation
Umbilical Cord Blood Transplantation
Thiotepa — full drug profile →

Conditions studied

Acute Biphenotypic Leukemia — all drugs for Acute Biphenotypic Leukemia →
Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
Burkitt Lymphoma — all drugs for Burkitt Lymphoma →

Sponsor

Fred Hutchinson Cancer Center — full company profile →

Who can join

Adults 6 Months to 65, any sex, with Acute Biphenotypic Leukemia or Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Survival Primary · 1 year post-transplant

Overall survival defined as patient being alive at 1 year post-transplant. Monitoring will take place separately for the single and double UCBT cohorts.

Group	Value	95% CI
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant	28
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant	15
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant	53
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant	7

Change in Level of Chimerism at Multiple Time Points Secondary · Baseline up to 2 years post-transplant

Peripheral blood chimerism studies (sorted for CD3, CD14, CD33, CD56 cells) were collected for all UCBT recipients for days 28, 56, 80, 365, and 730 post-transplant. The combined median of the percent donor, along with full range, is captured to show change in level of chimerism at multiple time points up to 2 years post-transplant. Monitoring will take place separately for the single and double UCBT cohorts.

Combined median of CD3 at days (24, 56, 80, 180, 365, 730)

Group	Value	95% CI
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant	100	44 – 100
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant	100	69 – 100
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant	100	67 – 100
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant	100	88 – 100

Combined median of CD14 at days (24, 56, 80, 180, 365, 730)

Group	Value	95% CI
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant	100	0 – 100
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant	100	100 – 100
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant	100	91 – 100
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant	100	100 – 100

Combined median of CD33 at days (24, 56, 80, 180, 365, 730)

Group	Value	95% CI
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant	100	99 – 100
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant	100	98 – 100
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant	100	50 – 100
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant	100	91 – 100

Combined median of CD56 at days (24, 56, 80, 180, 365, 730)

Group	Value	95% CI
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant	100	0 – 100
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant	100	100 – 100
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant	100	60 – 100
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant	100	90 – 100

Incidence of Transplant-related Mortality (TRM) Secondary · At 6 months post-transplant

Defined as death due to complication (other than relapse) within 6 months following UCBT. Monitoring will take place separately for the single and double UCBT cohorts.

Group	Value	95% CI
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant	2
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant	1
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant	9
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant	1

Neutrophil Engraftment Secondary · Up to day 42 post-transplant

Neutrophil engraftment after UCBT is defined as the first day of absolute neutrophil count (ANC) ≥ 5 x 10⁸/L for 3 consecutive measures. Monitoring will take place separately for the single and double UCBT cohorts.

Group	Value	95% CI
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant	19	12 – 42
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant	19	13 – 40
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant	22	12 – 39
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant	20	15 – 29

Platelet Engraftment Secondary · Up to 6 months post-transplant

Platelet (PLT) engraftment after UCBT is defined as the first day of platelet count \> 20,000/μl without subsequent transfusions for 7 days. Monitoring will take place separately for the single and double UCBT cohorts.

Group	Value	95% CI
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant	34	21 – 82
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant	35	18 – 90
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant	41	22 – 158
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant	37	30 – 56

Event of Grade II-IV and III-IV Acute Graft-versus-host Disease (aGVHD) Secondary · Up to day 100 post-transplant

Each event of aGVHD will be assigned an overall aGVHD score based on extent of skin rash, volume of diarrhea, and maximum bilirubin level, per protocol Appendix I, "GVHD Staging and Grading." Scores reported range from most mild at 2, to worse at 4. Monitoring will take place separately for the single and double UCBT cohorts.

Grade II-IV aGVHD

Group	Value	95% CI
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant	29
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant	14
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant	51
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant	5

Grade III-IV aGVHD

Group	Value	95% CI
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant	7
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant	2
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant	17
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant	1

Event of Chronic Graft-verses-host-disease (cGVHD) Secondary · Up to 2 years post-transplant

Each event of cGVHD level will be assessed overall as either 'Limited' (mild and with single organ involvement) or 'Extensive' (involvement of two or more organs with symptoms) based on extent of skin rash, volume of diarrhea, and maximum bilirubin level, per protocol Appendix I, "GVHD Staging and Grading." Monitoring will take place separately for the single and double UCBT cohorts.

Limited cGVHD

Group	Value	95% CI
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant	12
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant	6
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant	11
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant	5

Extensive cGVHD

Group	Value	95% CI
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant	14
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant	5
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant	44
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant	2

Event of Clinically Significant Infections Secondary · Up to 2 years post-transplant

Each event of infection will be assessed to determine whether or not it is clinically significant. An infection is defined as clinically significant when it is scored as ≥ grade 3 (where worse outcomes are associated with higher grading) in accordance with the CTCAE version 3.0/protocol Appendix VI, and constitutes a Serious Adverse Event (SAE). Monitoring will take place separately for the single and double UCBT cohorts.

Group	Value	95% CI
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant	2
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant	0
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant	21
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant	1

Incidence of Relapse Secondary · At 1 and 2 years post-transplant

Relapse is defined as post-transplant disease recurrence in participants who had initially recovered or improved, with incidence measured from Day 0 to 1 year post-transplant, and from 1 year post-transplant to 2 years post-transplant. Monitoring will take place separately for the single and double UCBT cohorts.

Group	Value	95% CI
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant	2
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant	4
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant	11
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant	0
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant	0
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant	0
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant	0
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant	1
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant	31
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant	13
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant	61
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant	9

Progression-free Survival (PFS) Secondary · Up to 2 years post-transplant

PFS is defined as the time (in days) from UCBT until the disease progresses or the patient dies from any cause, with incidence measured up to 2 years post-transplant. Monitoring will take place separately for the single and double UCBT cohorts. Measure will be reported as the median amount of days from full minimum and maximum range.

Group	Value	95% CI
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant	167	90 – 181
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant	155	32 – 194
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant	112	6 – 353
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant	317	55 – 724

Adverse events — posted to ClinicalTrials.gov

Time frame: Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide

Serious: 47/108 (44%)

Deaths: 24/108

Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa

Serious: 7/27 (26%)

Deaths: 9/27

Serious adverse events (36 terms)

Reaction	System	Regimen A: High-dose TBI +…	Regimen B: Middle-intensit…
Diarrhea	Gastrointestinal disorders	—	—
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)	Infections and infestations	—	—
Infection with normal ANC or Grade 1 or 2 neutrophils - Blood	Infections and infestations	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—
Hypotension	Vascular disorders	—	—
Infection with Grade 3 or 4 neutrophils - Bladder or urinary tract	Infections and infestations	—	—
Death not associated with CTCAE term - Multi-organ failure	General disorders	—	—
Acute kidney injury (AKI)	Renal and urinary disorders	—	—
Renal failure	Renal and urinary disorders	—	—
Acute Respiratory Distress Syndrome (ARDS)	Respiratory, thoracic and mediastinal disorders	—	—
Encephalopathy	Nervous system disorders	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—
Hemorrhage, pulmonary/ upper respiratory	Respiratory, thoracic and mediastinal disorders	—	—
Hypertension	Vascular disorders	—	—
Seizure	Nervous system disorders	—	—
Liver dysfunction/failure (clinical)	Hepatobiliary disorders	—	—
Bilirubin (hyperbilirubinemia)	Metabolism and nutrition disorders	—	—
Syncope (fainting)	Nervous system disorders	—	—
Potassium, serum-high (hyperkalemia)	Metabolism and nutrition disorders	—	—
Acute infusion reaction	Injury, poisoning and procedural complications	—	—
Cardiopulmonary arrest, cause unknown (non-fatal)	Cardiac disorders	—	—
Cholecystitis	Hepatobiliary disorders	—	—
Confusion	Psychiatric disorders	—	—
Pain - Select: Head/headache	Nervous system disorders	—	—
Infection with Grade 3 or 4 neutrophils - Blood	Infections and infestations	—	—

Other adverse events (71 terms — click to expand)

Reaction	System	Regimen A: High-dose TBI +…	Regimen B: Middle-intensit…
Rash/desquamation	Skin and subcutaneous tissue disorders	—	—
Infection in blood	Infections and infestations	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—
Mucositis	Gastrointestinal disorders	—	—
Hypertension	Cardiac disorders	—	—
Infection in respiratory tract	Infections and infestations	—	—
Infection in urinary tract (urinary tract infection; UTI)	Infections and infestations	—	—
Hypotension	Blood and lymphatic system disorders	—	—
Hyperbilirubinemia	Investigations	—	—
Infection, Other	Infections and infestations	—	—
Anorexia	Gastrointestinal disorders	—	—
Hemorrhage/bleeding	General disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Disseminated Adenovirus (ADV)	Infections and infestations	—	—
Infection in gastrointestinal tract	Infections and infestations	—	—
Hemolysis	Blood and lymphatic system disorders	—	—
Cytomegalovirus virus (CMV) reactivation	Infections and infestations	—	—
Pain	General disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—
Thrombotic microangiopathy (TMA)	Blood and lymphatic system disorders	—	—
Fever	General disorders	—	—
Acute kidney injury (AKI)	Renal and urinary disorders	—	—
Alanine aminotransferase (ALT) increased, SGPT (serum glutamic pyruvic transaminase)	Investigations	—	—
Gastritis	Gastrointestinal disorders	—	—
Renal/Genitourinary, Other (Veno-occlusive disease [VOD])	Renal and urinary disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Allergic reaction/hypersensitivity	Immune system disorders	—	—
CD4 count	Blood and lymphatic system disorders	—	—
Iron overload	Blood and lymphatic system disorders	—	—
Supraventricular and nodal arrhythmia	Cardiac disorders	—	—
Prolonged QTc interval	Cardiac disorders	—	—
Coagulation, Other (Coagulopathy)	Blood and lymphatic system disorders	—	—
Fatigue	General disorders	—	—
Aspartate aminotransferase increased (AST)	Investigations	—	—
Mood alteration - Depression	Psychiatric disorders	—	—
Encephalopathy	Nervous system disorders	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—
Hyperkalemia	Metabolism and nutrition disorders	—	—
Hypermagnesemia	Metabolism and nutrition disorders	—	—

Most-reported serious reactions: Diarrhea, Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia), Infection with normal ANC or Grade 1 or 2 neutrophils - Blood, Hypoxia, Hypotension, Infection with Grade 3 or 4 neutrophils - Bladder or urinary tract, Death not associated with CTCAE term - Multi-organ failure, Acute kidney injury (AKI).

Data from ClinicalTrials.gov NCT00719888 adverse events section.

Sponsor's own description

This phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide, fludarabine, and total-body irradiation (TBI) works in treating patients with hematologic disease. Giving chemotherapy, such as cyclophosphamide and fludarabine, and TBI before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Persistence of the losing cord blood unit following double cord blood transplantation: finding the unseen.
Milano F, Gammill H, Oliver DC, Kanaan SB, et al · · 2017 · cited 4× · PMID 28765258 · DOI 10.1182/blood-2017-06-788513

Verify or expand the search:

Other trials of Cyclophosphamide

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Currently open trials in the same condition.

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NCT03779854 — Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers · Phase 2 · recruiting

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00719888 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fred Hutchinson Cancer Center
Last refreshed: 7 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00719888.

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