Overall Survival
Primary
· At 1 year
Kaplan-Meier and cumulative incidence estimates will be used.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Chemotherapy, Transplant) | 35 |
Last reviewed · How we verify
NCT00723099
Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer
Completed
Phase 2
Results posted
Last updated 27 December 2019
What this trial tests
Phase 2 trial testing Allogeneic Hematopoietic Stem Cell Transplantation in Acute Lymphoblastic Leukemia in 73 participants. Completed in 31 July 2018.
Timeline
25 June 2008
Primary endpoint
31 July 2018
31 July 2018
31 July 2018
Quick facts
| Lead sponsor | Fred Hutchinson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 73 |
| Start date | 25 June 2008 |
| Primary completion | 31 July 2018 |
| Estimated completion | 31 July 2018 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- Allogeneic Hematopoietic Stem Cell Transplantation
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Cyclosporine (cyclosporine) — full drug profile →
- Fludarabine Phosphate (FLUDARABINE PHOSPHATE) — full drug profile →
- Laboratory Biomarker Analysis
- Mycophenolate Mofetil (MYCOPHENOLATE MOFETIL) — full drug profile →
- Total-Body Irradiation
- Umbilical Cord Blood Transplantation
Conditions studied
- Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
- Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
- Aggressive Non-Hodgkin Lymphoma — all drugs for Aggressive Non-Hodgkin Lymphoma →
- Chronic Myelogenous Leukemia — all drugs for Chronic Myelogenous Leukemia →
Sponsor
Fred Hutchinson Cancer Center — full company profile →
Who can join
Under 69, any sex, with Acute Lymphoblastic Leukemia or Acute Myeloid 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.
Median Time to ANC > 500
Secondary
· By day 55
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Chemotherapy, Transplant) | 18 | 2 – 46 |
Number of Participants With Graft Failure/Rejection
Secondary
· By day 55
descriptive
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Chemotherapy, Transplant) | 3 |
Time to Platelet Engraftment of > 20,000 Cells Per mm3
Secondary
· By 6 months
median and range
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Chemotherapy, Transplant) | 46 | 7 – 161 |
Percent of Patients With Grade II-IV Acute Graft Versus Host Disease
Secondary
· By day 100
Chi-square test was used to determine percent of grade II-IV GVHD using Glucksberg criteria
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Chemotherapy, Transplant) | 67 |
Percent of Patients With Acute GVHD Grades III-IV
Secondary
· 100 days
Fischer's exact test was used to determined percent of patients with acute grade III-IV GVHD by Glucksberg criteria
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Chemotherapy, Transplant) | 12 |
Percent of Patients With Chronic GVHD
Secondary
· At 2 years
Kaplan-Meier and cumulative incidence estimates will be used to measure percent of patients with chronic GVHD by NIH consensus criteria.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Chemotherapy, Transplant) | 19 |
Percent of Patients With Non-relapse Mortality
Secondary
· 6 months
Kaplan-Meier and cumulative incidence estimates
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Chemotherapy, Transplant) | 21 |
Percent of Patients With Non-relapse Mortality
Secondary
· 1 year
Kaplan-Meier and cumulative incidence estimates
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Chemotherapy, Transplant) | 38 |
Adverse events — posted to ClinicalTrials.gov
Time frame: 100 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Chemotherapy, Transplant)
Serious: 18/72 (25%)
Deaths: 52/72
Serious adverse events (15 terms)
| Reaction | System | Treatment (Chemotherapy, T… |
|---|---|---|
| Encephalopathy | Nervous system disorders | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Diffuse Alveolar Hemorrhage | Respiratory, thoracic and mediastinal disorders | — |
| Sepsis | Infections and infestations | — |
| Syncope | Cardiac disorders | — |
| Heart Failure | Cardiac disorders | — |
| Renal Failure | Renal and urinary disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Bladder Hemorrhage | Renal and urinary disorders | — |
| Intracerebral Hemorrhage | Nervous system disorders | — |
| Myocardial Infarction | Cardiac disorders | — |
| Arrythmia | Cardiac disorders | — |
| Fever and rash | Skin and subcutaneous tissue disorders | — |
| Encephalitis | Infections and infestations | — |
| Hypertension | Cardiac disorders | — |
Other adverse events (38 terms — click to expand)
| Reaction | System | Treatment (Chemotherapy, T… |
|---|---|---|
| Febrile Neutropenia | Infections and infestations | — |
| Hyperbilirubinemia | Hepatobiliary disorders | — |
| Infection-Lung | Infections and infestations | — |
| Infection-GU | Infections and infestations | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Infection-Blood | Infections and infestations | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Hypotension | Cardiac disorders | — |
| Infection-GI | Infections and infestations | — |
| Diffuse Alveolar Hemorrhage | Blood and lymphatic system disorders | — |
| Renal Failure | Renal and urinary disorders | — |
| orthostatic hypotension | Cardiac disorders | — |
| Thrombosis | Cardiac disorders | — |
| Left ventricular function decrease | Cardiac disorders | — |
| Arrythmia | Cardiac disorders | — |
| Encephalopathy | Nervous system disorders | — |
| Coagulopathy | Blood and lymphatic system disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| allergic reaction | Immune system disorders | — |
| Infection-Oral Cavity | Infections and infestations | — |
| Infection skin | Infections and infestations | — |
| Infection CNS | Infections and infestations | — |
| Bladder Hemorrhage | Renal and urinary disorders | — |
| Colitis | Gastrointestinal disorders | — |
| Mucositis | Gastrointestinal disorders | — |
| hemolysis | Blood and lymphatic system disorders | — |
| Troponin elevation | Cardiac disorders | — |
| Myocardial infarction | Cardiac disorders | — |
| Pericarditis | Cardiac disorders | — |
| Hemolytic Anemia | Blood and lymphatic system disorders | — |
| Hemolytic Uremic syndrome | Renal and urinary disorders | — |
| Hepatic Failure | Hepatobiliary disorders | — |
| Infection-joint | Infections and infestations | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Syncope | Nervous system disorders | — |
| seizure | Nervous system disorders | — |
| Vaginal Bleeding | Renal and urinary disorders | — |
| Small Bowel Obstruction | Gastrointestinal disorders | — |
Most-reported serious reactions: Encephalopathy, Respiratory failure, Diffuse Alveolar Hemorrhage, Sepsis, Syncope, Heart Failure, Renal Failure, Hypoxia.
Data from ClinicalTrials.gov NCT00723099 adverse events section.
Sponsor's own description
This phase II trial is studying how well umbilical cord blood transplant from a donor works in treating patients with hematological cancer. Giving chemotherapy and total-body irradiation (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 an unrelated donor, that do not exactly match the patient's blood, 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 (called graft-versus-host disease). Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00723099
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Fred Hutchinson Cancer Center trials
Trials by the same sponsor.
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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 NCT00723099 (US National Library of Medicine, public domain)
- 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: 27 December 2019
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/NCT00723099.
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