NCT00571662 is a Phase 2 clinical trial of Pentostatin in Acute Myelogenous Leukemia, sponsored by University of Nebraska.

Who is sponsoring NCT00571662?

NCT00571662 is sponsored by University of Nebraska.

What drugs are being tested in NCT00571662?

Interventions in NCT00571662: Pentostatin, Total-body irradiation (TBI), Cyclosporine A (CsA), Mycophenolate Mofetil (MMF), G-CSF.

What condition does NCT00571662 study?

NCT00571662 studies Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Chronic Lymphocytic Leukemia, Myelodysplastic Syndromes, Multiple Myeloma, Non-Hodgkins Lymphoma, Hodgkins Disease, Peripheral T-cell Lymphoma.

Is NCT00571662 still recruiting?

NCT00571662 is currently completed. Last updated 24 October 2023.

Are results published for NCT00571662?

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

Last reviewed 2023-10-24 · How we verify

NCT00571662

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

Safety and Efficacy of Pentostatin and Low Dose TBI With Allogenic Peripheral Blood Stem Cell Transplant

Completed Phase 2 Results posted Last updated 24 October 2023

What this trial tests

Phase 2 trial testing Pentostatin in Acute Myelogenous Leukemia in 76 participants. Completed in 30 December 2008.

Timeline

8 December 2000

Primary endpoint
30 December 2008

30 December 2008

Quick facts

Lead sponsor	University of Nebraska
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	76
Start date	8 December 2000
Primary completion	30 December 2008
Estimated completion	30 December 2008
Sites	1 location across United States

Drugs / interventions tested

Pentostatin (PENTOSTATIN) — full drug profile →
Total-body irradiation (TBI)
Cyclosporine A (CsA) — full drug profile →
Mycophenolate Mofetil (MMF) — full drug profile →
G-CSF (g-csf) — full drug profile →

Conditions studied

Acute Myelogenous Leukemia — all drugs for Acute Myelogenous Leukemia →
Acute Lymphocytic Leukemia — all drugs for Acute Lymphocytic Leukemia →
Chronic Myelogenous Leukemia — all drugs for Chronic Myelogenous Leukemia →
Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →

Sponsor

University of Nebraska

Who can join

Adults 19 to 75, any sex, with Acute Myelogenous Leukemia or Acute Lymphocytic 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.

Percent of Participants With Chimerism: Full Donor Chimerism Defined as >95% Donor CD3+ Cell in Blood as Assessed by DNA Fingerprinting Primary · days +28 and +70

the efficacy of the regimen as determined by engraftment rate and establishment of donor hematopoietic chimerism at day +28 and day +70.

Day 28

Group	Value	95% CI
Cohort I	85	40 – 100

Day 70

Group	Value	95% CI
Cohort I	90	45 – 100

Toxicity for the Combination of Pentostatin and Low Dose Total Body Irradiation (TBI) Primary · Conditioning regimen to count recovery (D + 28 post transplant)

Absolute neutrophil count < 500/mm^3

Group	Value	95% CI
Cohort I	40

platelet count < 20,000/mm^3

Group	Value	95% CI
Cohort I	29

Grade 3 or 4 Fever

Group	Value	95% CI
Cohort I	2

Grade 3 or 4 hypokalemia

Group	Value	95% CI
Cohort I	1

Grade 3 or 4 bacteremia

Group	Value	95% CI
Cohort I	2

Grade 3 or 4 infection

Group	Value	95% CI
Cohort I	6

Grade 3 or 4 renal toxicity

Group	Value	95% CI
Cohort I	1

Grade 3 or 4 thromboembolism

Group	Value	95% CI
Cohort I	1

Incidence of Acute and Chronic Graft-versus-host Disease Secondary · twice weekly until day 100 up to 1 year post transplant

Incidence of acute and chronic graft-versus-host disease. Acute GVHD usually occurs during the first three months following transplant. Chronic GVHD usually develops after the third month post-transplant.

Acute GVHD

Group	Value	95% CI
Cohort I	31

Chronic GVHD

Group	Value	95% CI
Cohort I	33

Responses to Therapy Secondary · every 6 mo. up to 2 years

event-free and overall survival at 12 months

Event free survival

Group	Value	95% CI
Cohort I	52

Overall survival

Group	Value	95% CI
Cohort I	59

Kinetics of Immunologic Reconstitution Secondary · at day 100 post transplantation

Rate of return of immune cells after allogeneic transplantation

CD3 cells

Group	Value	95% CI
Study Baseline	13	0.5 – 45
Day + 28 Post Transplant	7	0 – 28

CD4 cells

Group	Value	95% CI
Study Baseline	5	0.01 – 25
Day + 28 Post Transplant	3.5	0 – 13

CD8 cells

Group	Value	95% CI
Study Baseline	5	0 – 31
Day + 28 Post Transplant	1.7	0.02 – 8.3

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort I

Serious: 26/76 (34%)

Deaths: —

Serious adverse events (15 terms)

Reaction	System	Cohort I
decreased WBC	Blood and lymphatic system disorders	—
decreased ANC	Blood and lymphatic system disorders	—
fever	General disorders	—
decreased platelets	Blood and lymphatic system disorders	—
decreased hgb	Blood and lymphatic system disorders	—
hypokalemia	Gastrointestinal disorders	—
decreased leukocyte	Blood and lymphatic system disorders	—
klebsiella	Cardiac disorders	—
reddened catheter site	Infections and infestations	—
herpes simplex	Immune system disorders	—
Yeast infection	Renal and urinary disorders	—
increased LDH	Hepatobiliary disorders	—
pulmonary embolism	Blood and lymphatic system disorders	—
azotemia	Renal and urinary disorders	—
atubular necrosis	Renal and urinary disorders	—

Most-reported serious reactions: decreased WBC, decreased ANC, fever, decreased platelets, decreased hgb, hypokalemia, decreased leukocyte, klebsiella.

Data from ClinicalTrials.gov NCT00571662 adverse events section.

Sponsor's own description

This is a continuation of a pilot study which is now regarded as a phase II trial with a plan to enroll an additional 40 patients (20 related and 20 unrelated donor transplants) with hematological malignancy assessing the safety and efficacy of a minimally myelosuppressive regimen with pentostatin and low-dose total body irradiation (TBI) followed by allogeneic peripheral blood stem cell transplantation (alloPSCT).

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:

Other trials of Pentostatin

Trials testing the same drug.

NCT05757310 — A Reduced-Intensity Conditioning Regimen (Cyclophosphamide, Pentostatin, Anti-thymocyte Globulin) Followed by Haploident · Phase 1 · recruiting
NCT03249831 — A Blood Stem Cell Transplant for Sickle Cell Disease · Phase 1 · active not recruiting
NCT03663933 — Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation · Phase 2 · active not recruiting
NCT03112603 — A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Diseas · Phase 3 · completed
NCT03077542 — Nonmyeloablative Haploidentical Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell · Phase 1, PHASE2 · active not recruiting

Other recruiting trials for Acute Myelogenous Leukemia

Currently open trials in the same condition.

NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
NCT06904482 — Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood · Phase 2 · recruiting
NCT06680661 — ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis · Phase 2 · recruiting
NCT06131801 — Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution · recruiting
NCT05974150 — Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia · recruiting

Other University of Nebraska trials

Trials by the same sponsor.

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NCT07506993 — Inflammation in Clear Aligners With and Without Attachments · not yet recruiting
NCT07207850 — Parents Helping Parents for Youth Vaping Cessation · NA · not yet recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting

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 NCT00571662 (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 University of Nebraska
Last refreshed: 24 October 2023

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/NCT00571662.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing