Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01036009 · ClinicalTrials.gov registry record · Phase 2
A Study of Withdrawal of Immunosuppression and Donor Lymphocyte Infusions Following Allogeneic Transplant for Pediatric Hematologic Malignancies
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT01036009: Completed Phase 2 study, sponsored by University of California, San Francisco.
NCT01036009 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01036009, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
There is no curative therapy once acute leukemia patients relapse after transplant. Patients who develop clinically significant graft versus host disease (GVHD) have a lower rate of relapse than those who do not develop GVHD. We are initiating this study of post-transplant fast withdrawal of immunosuppression and donor lymphocyte infusions, with a goal of achieving full donor chimerism in children with hematologic malignancies. If our hypothesis that full donor chimerism results in leukemia-free survival is correct, using immune modulation to achieve full donor chimerism should decrease relapse rate and thus increase survival. The goal of this Phase II study is to identify if achieving full donor chimerism in whole blood CD3+ and leukemia-specific (CD14/15+, CD19+, CD33+ and CD34+) subset may decrease the risk of relapse of patients undergoing allogeneic transplant for hematologic malignancy.
Primary Outcome
Definition of relapse was \>5 % blasts in bone marrow
Interventions
- OTHER Withdrawal of immunosuppression and donor lymphocyte infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2009-10 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
What the finished NCT01036009 record still lists
NCT01036009 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which Withdrawal of immunosuppression and donor lymphocyte infusion is the first listed.
NCT01036009 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01036009 about?
NCT01036009 is a clinical study titled "A Study of Withdrawal of Immunosuppression and Donor Lymphocyte Infusions Following Allogeneic Transplant for Pediatric Hematologic Malignancies". There is no curative therapy once acute leukemia patients relapse after transplant. Patients who develop clinically significant graft versus host disease (GVHD) have a lower rate of relapse than those who do not develop GVHD. We are initiating this study of post-transplant fast withdrawal of immunos...
What is the current status of trial NCT01036009?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2009-10. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01036009?
The interventions under investigation include: Withdrawal of immunosuppression and donor lymphocyte infusion (OTHER).
Who is sponsoring clinical trial NCT01036009?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01036009's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03726359 · 43 participants · Phase 1
Phase I Study of Fractionated Stereotactic Radiation Therapy
- NCT03850418 · 43 participants · Phase 2
Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant
- NCT04144023 · 43 participants · Phase 1
A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ
- NCT04176718 · 43 participants · Phase 2
Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia