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NCT01894477
A Randomized Phase II Study of Treosulfan, Fludarabine and Low-Dose TBI as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML)
Phase 2 trial testing Allogeneic Bone Marrow Transplantation in Acute Myeloid Leukemia in Remission in 102 participants. Status unknown.
9 January 2017
Quick facts
| Lead sponsor | Fred Hutchinson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 102 |
| Start date | 1 November 2013 |
| Primary completion | 9 January 2017 |
| Estimated completion | 1 June 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Allogeneic Bone Marrow Transplantation
- Fludarabine Phosphate (FLUDARABINE PHOSPHATE) — full drug profile →
- Peripheral Blood Stem Cell Transplantation — full drug profile →
- Total-Body Irradiation
- Treosulfan (TREOSULFAN) — full drug profile →
- Laboratory Biomarker Analysis — full drug profile →
Conditions studied
- Acute Myeloid Leukemia in Remission — all drugs for Acute Myeloid Leukemia in Remission →
- Chronic Myelomonocytic Leukemia — all drugs for Chronic Myelomonocytic Leukemia →
- Minimal Residual Disease — all drugs for Minimal Residual Disease →
- Myelodysplastic Syndrome — all drugs for Myelodysplastic Syndrome →
Sponsor
Fred Hutchinson Cancer Center — full company profile →
Who can join
Under 70, any sex, with Acute Myeloid Leukemia in Remission or Chronic Myelomonocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Participants That Did Not Progress Within 6 Months
Time frame: At 6 months post-transplant
Progression is defined as relapse
Sponsor's own description
This randomized phase II trial studies how well treosulfan and fludarabine phosphate, with or without total body irradiation before donor stem cell transplant works in treating patients with myelodysplastic syndrome or acute myeloid leukemia. Giving chemotherapy, such as treosulfan and fludarabine phosphate, and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus before and mycophenolate mofetil after the transplant may stop this from happening.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01894477
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Allogeneic Bone Marrow Transplantation
Trials testing the same drug.
- NCT04965597 — Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure · Phase 2 · completed
- NCT03856216 — Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantati · Phase 2 · terminated
- NCT03779854 — Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers · Phase 2 · recruiting
- NCT02333162 — Intensity Modulated Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients With Relapsed He · Phase 1 · suspended
- NCT02083250 — Fludarabine Phosphate, Clofarabine, and Busulfan With Vorinostat in Treating Patients With Acute Leukemia in Remission o · Phase 1 · completed
Other recruiting trials for Acute Myeloid Leukemia in Remission
Currently open trials in the same condition.
- NCT06440135 — Ziftomenib Maintenance Post Allo-HCT · Phase 1 · recruiting
- NCT06462365 — Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem Cell Transplant (HSCT) · Phase 1 · recruiting
- NCT05236764 — Haploidentical Hematopoietic Cell Transplantation Using TCR Alpha/Beta and CD19 Depletion · NA · active not recruiting
- NCT05917405 — Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT · Phase 2 · recruiting
- NCT05224661 — Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events · active not recruiting
Other Fred Hutchinson Cancer Center trials
Trials by the same sponsor.
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- NCT07176000 — Tailored Patient Navigation to Improve the Uptake of Lung Cancer Screening in Tribal Communities in Western Washington S · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01894477 (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: 13 May 2021
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/NCT01894477.
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