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NCT02996773
Haploidentical BMT With Post-Transplant Cyclophosphamide and Bendamustine
Phase 1 trial testing Bendamustine in Acute Lymphoblastic Leukemia in 50 participants. Completed in 1 August 2025.
1 August 2025
Quick facts
| Lead sponsor | University of Arizona |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 29 November 2016 |
| Primary completion | 1 August 2025 |
| Estimated completion | 1 August 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Bendamustine (BENDAMUSTINE) — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
Conditions studied
- Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
- Acute Myelogenous Leukemia — all drugs for Acute Myelogenous Leukemia →
- Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →
- Chronic Myelogenous Leukemia — all drugs for Chronic Myelogenous Leukemia →
Sponsor
University of Arizona
Who can join
Adults 4 to 30, any sex, with Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the safety of progressively substituting day +3 and +4 post-transplant cyclophosphamide (PT-CY) with post-transplant bendamustine (PT-BEN) in myeloablative (MAC) haploidentical hematopoietic cell transplantation (HHCT) for patients with hematological malignancies. The goal of the Phase 1 component of the study is to evaluate the safety of progressively substituting post-transplant cyclophosphamide (PT-CY) given on Days +3 and +4 with bendamustine (PT-BEN). The Phase I component of the study has been completed. The Phase Ib component of the study will continue to evaluate the safety and efficacy of subjects who receive PT-BEN on Days +3 and +4 at the maximum tolerated dose determined by Phase I. The Phase Ib component of the study has been completed. Approximately, 18-36 subjects will be treated as part of Phase I and 15 as part of Phase Ib. Approximately 18 subjects will be used as controls, subjects that receive no PET-BEN, for direct comparison. Total, approximately 38-56 treatment and control patients and 38-56 donor subjects will be enrolled.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Prevention and Treatment of Acute Graft-versus-Host Disease in Children, Adolescents, and Young Adults.
Gatza E, Reddy P, Choi SW. · · 2020 · cited 41× · PMID 31931115 · DOI 10.1016/j.bbmt.2020.01.004 -
Haploidentical Bone Marrow Transplantation with Post-Transplant Cyclophosphamide/Bendamustine in Pediatric and Young Adult Patients with Hematologic Malignancies.
Katsanis E, Sapp LN, Varner N, Koza S, et al · · 2018 · cited 30× · PMID 29908231 · DOI 10.1016/j.bbmt.2018.06.007 -
New therapeutic targets and biomarkers for acute graft-versus-host disease (GVHD).
Choe H, Ferrara JLM. · · 2021 · cited 25× · PMID 34669521 · DOI 10.1080/14728222.2021.1992383 -
T-Cell Replete Myeloablative Haploidentical Bone Marrow Transplantation Is an Effective Option for Pediatric and Young Adult Patients With High-Risk Hematologic Malignancies.
Katsanis E, Sapp LN, Reid SC, Reddivalla N, et al · · 2020 · cited 22× · PMID 32582591 · DOI 10.3389/fped.2020.00282 -
Immunomodulatory Effects of Bendamustine in Hematopoietic Cell Transplantation.
Stokes J, Molina MS, Hoffman EA, Simpson RJ, et al · · 2021 · cited 19× · PMID 33916711 · DOI 10.3390/cancers13071702 -
Progressive substitution of posttransplant cyclophosphamide with bendamustine: A phase I study in haploidentical bone marrow transplantation.
Katsanis E, Maher K, Roe DJ, Simpson RJ. · · 2020 · cited 16× · PMID 35847727 · DOI 10.1002/jha2.20 -
Bendamustine Conditioning Skews Murine Host DCs Toward Pre-cDC1s and Reduces GvHD Independently of Batf3.
Molina MS, Stokes J, Hoffman EA, Eremija J, et al · · 2020 · cited 14× · PMID 32765499 · DOI 10.3389/fimmu.2020.01410 -
Commentary: Post-Transplantation Cyclophosphamide Uniquely Restrains Alloreactive CD4+ T-Cell Proliferation and Differentiation After Murine MHC-Haploidentical Hematopoietic Cell Transplantation.
Stokes J, Simpson RJ, Katsanis E. · · 2022 · cited 6× · PMID 35493453 · DOI 10.3389/fimmu.2022.887648
Verify or expand the search:
- PubMed search for NCT02996773
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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- Google Scholar
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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)
- Trial protocol + status: ClinicalTrials.gov NCT02996773 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 University of Arizona
- Last refreshed: 10 November 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/NCT02996773.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing