Fludarabine and Intermediate-dose TBI Followed by PTCy in Patients Undergoing Allo Transplant for Heme Malignancies
NCT ID: NCT07214688
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
209 participants
INTERVENTIONAL
2025-11-15
2031-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental
Fludarabine and Intermediate-dose Total Body Irradiation (800 cGy) Followed by Post-transplant Cyclophosphamide
Fludarabine
Patients will receive fludarabine administered at the dose of 30 mg/m2 intravenously daily on Days -6 to -2
Intermediate-dose Total Body Irradiation (TBI)
Patients will receive intermediate-dose total body irradiation (TBI) administered at the dose of 800 cGy in 4 total fractions, 2 fractions per day on Days -2 to -1
Post-transplant Cyclophosphamide (PTCy)
Patients will receive post-transplant cyclophosphamide (PTCy) administered at the dose of 40 mg/kg intravenously on Days +3 to +4.
Tacrolimus
Patients will receive tacrolimus administered at a dose adjusted to maintain trough levels between 5-15 ng/mL orally starting on Days +5.
Mycophenolate mofetil (MMF)
Patients will receive mycophenolate mofetil (MMF) administered at the standard dose of 15 mg/kg orally three times daily starting on Day +5 to Day +35 or per institutional guidelines.
Interventions
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Fludarabine
Patients will receive fludarabine administered at the dose of 30 mg/m2 intravenously daily on Days -6 to -2
Intermediate-dose Total Body Irradiation (TBI)
Patients will receive intermediate-dose total body irradiation (TBI) administered at the dose of 800 cGy in 4 total fractions, 2 fractions per day on Days -2 to -1
Post-transplant Cyclophosphamide (PTCy)
Patients will receive post-transplant cyclophosphamide (PTCy) administered at the dose of 40 mg/kg intravenously on Days +3 to +4.
Tacrolimus
Patients will receive tacrolimus administered at a dose adjusted to maintain trough levels between 5-15 ng/mL orally starting on Days +5.
Mycophenolate mofetil (MMF)
Patients will receive mycophenolate mofetil (MMF) administered at the standard dose of 15 mg/kg orally three times daily starting on Day +5 to Day +35 or per institutional guidelines.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with a diagnosis of one of the following hematologic malignancies:
* Acute myeloid leukemia or chronic myeloid leukemia with no circulating blasts and less than 5% blasts in the bone marrow;
* Myelodysplastic syndrome with less than 5% blasts in the bone marrow by IHC or flow cytometry whichever is highest;
* Myeloproliferative neoplasms with less than 5% blast in the marrow and peripheral blood;
* Acute lymphoblastic leukemia in CR (CIBMTR criteria); or Lymphoma in CR (CIBMTR criteria).
* Patients who are eligible for allogeneic stem cell transplant per Transplant Program SOPs.
* Patients with a Karnofsky performance status (KPS) of ≥60%.
* Patients with adequate organ function defined by:
* Cardiac: LVEF ≥50%
* Pulmonary: DLCO ≥50% of predicted
* Hepatic: Bilirubin ≤1.5x ULN, ALT/AST ≤2.5x ULN
* Renal: Creatinine clearance ≥50 mL/min
* All participants of reproductive potential must use effective contraception following allogeneic hematopoietic stem cell transplantation (allo-HSCT), in accordance with guidelines from the American Society for Transplantation and Cellular Therapy (ASTCT), the FDA, and other expert bodies.
* For Male Participants:
○ Male participants must use effective contraception for at least 12 months after transplant, and longer if receiving immunosuppressive or cytotoxic medications. Chemotherapy and radiation can cause DNA damage to sperm, and even if fertility returns, mutations may persist for months. In cases where drugs such as mycophenolate mofetil (MMF) or lenalidomide are used, FDA guidance requires contraception for at least 90 days after discontinuation. Sperm cryopreservation should be offered prior to conditioning. Participants must avoid fathering a child during this time frame.15-17
* For Female Participants:
* Female participants of childbearing potential are required to use highly effective contraception for a minimum of 12 to 24 months post-transplant, or longer if still receiving immunosuppressive or teratogenic therapy. For drugs such as MMF, sirolimus, or ruxolitinib, contraception must continue for 3 months after the last dose.
* A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.15-17
* Patients with a suitable donor for allogeneic stem cell transplant defined by:
* Matched sibling donors willing to donate mobilized peripheral blood (PBSC) or bone marrow (BM), meeting all institutional criteria for donation;
* Unrelated donors at \>7/8 (i.e., mismatched at only one of the HLA-A, HLA-B, HLA-C, and HLA-DRB1 loci) willing to donate mobilized PBSC or BM, and medically eligible to donate cells according to National Marrow Donor Program criteria; or Related Haploidentical donors willing to donate PBSC or BM and meeting criteria for donation.
* Patients who are able to comply with follow-up visits and treatment plans.
* Patients who are able to give informed consent.
Exclusion Criteria
* Patients with a Karnofsky performance status (KPS) of \<60%.
* Patients with active infections or other contraindications for allogeneic stem cell transplant.
* Patients who are unable or unwilling to give informed consent.
* Patients who have received a prior allogeneic transplant.
* Patients who are unable to comply with follow-up visits and treatment plans.
18 Years
65 Years
ALL
No
Sponsors
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Hackensack Meridian Health
OTHER
Responsible Party
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Principal Investigators
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Michele Donato, MD
Role: PRINCIPAL_INVESTIGATOR
Hackensack Meridian Health
Locations
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Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
John Theurer Cancer Center at Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Countries
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Central Contacts
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Oncology Clinical Research Referral Office
Role: CONTACT
Phone: 551-996-1777
Email: [email protected]
Facility Contacts
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Pending
Role: primary
Oncology Clinical Research Referral Office
Role: primary
Oncology Clinical Research Referral Office
Role: primary
References
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Wu J, Chen L, Wei J, Weiss H, Chauhan A. Two-stage phase II survival trial design. Pharm Stat. 2020 May;19(3):214-229. doi: 10.1002/pst.1983. Epub 2019 Nov 21.
Mycophenolate REMS (Risk Evaluation and Mitigation Strategy). https://www.accessdata.fda.gov
Vaxman I, Muchtar E, Jacob E, Kapoor P, Kumar S, Dispenzieri A, Buadi F, Dingli D, Gonsalves W, Kourelis T, Warsame R, Lacy M, Hogan W, Gertz MA. The Efficacy and Safety of Chemotherapy-Based Stem Cell Mobilization in Multiple Myeloma Patients Who Are Poor Responders to Induction: The Mayo Clinic Experience. Transplant Cell Ther. 2021 Sep;27(9):770.e1-770.e7. doi: 10.1016/j.jtct.2021.06.016. Epub 2021 Jun 18.
Xhaard A, Rocha V, Bueno B, de Latour RP, Lenglet J, Petropoulou A, Rodriguez-Otero P, Ribaud P, Porcher R, Socie G, Robin M. Steroid-refractory acute GVHD: lack of long-term improved survival using new generation anticytokine treatment. Biol Blood Marrow Transplant. 2012 Mar;18(3):406-13. doi: 10.1016/j.bbmt.2011.06.012. Epub 2011 Jul 4.
Sengsayadeth S, Wang T, Lee SJ, Haagenson MD, Spellman S, Fernandez Vina MA, Muller CR, Verneris MR, Savani BN, Jagasia M. Cytotoxic T-lymphocyte antigen-4 single nucleotide polymorphisms are not associated with outcomes after unrelated donor transplantation: a center for international blood and marrow transplant research analysis. Biol Blood Marrow Transplant. 2014 Jun;20(6):900-3. doi: 10.1016/j.bbmt.2014.03.005. Epub 2014 Mar 14.
Przepiorka D, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995 Jun;15(6):825-8.
Lee JW, Cho BS, Lee SE, Eom KS, Kim YJ, Kim HJ, Lee S, Min CK, Cho SG, Min WS, Park CW. The Outcome of Unrelated Hematopoietic Stem Cell Transplants with Total Body Irradiation (800 cGy) and Cyclophosphamide (120 mg/kg) in Adult Patients with Acquired Severe Aplastic Anemia. Biol Blood Marrow Transplant. 2011 Jan;17(1):101-8. doi: 10.1016/j.bbmt.2010.06.014. Epub 2010 Jun 25.
Sanchez-Petitto G, Huang Y, Bezerra E, et al. Comparison of Two Myeloablative Total-Body Irradiation (MAC-TBI) Regimens: 1200 Cgy Vs 800 Cgy of TBI for Allogeneic Stem Cell Transplantation in Adults with Hematological Malignancies. Blood. 2024;144(Supplement 1):7303-7303. doi:10.1182/blood-2024-194146
Sterling CH, Hughes MS, Tsai HL, et al. Non-myeloablative allogeneic blood or marrow transplantation (AlloBMT) with post-transplant cyclophosphamide (PTCy) for peripheral T- cell lymphoma (PTCL): Improved outcomes with peripheral blood (PB) allografts and increased total body irradiation (TBI) to 400 cGV. J Clin Oncol. 2022;40(16_suppl):7047- 7047. doi:10.1200/JCO.2022.40.16_suppl.7047
Gooley TA, Chien JW, Pergam SA, Hingorani S, Sorror ML, Boeckh M, Martin PJ, Sandmaier BM, Marr KA, Appelbaum FR, Storb R, McDonald GB. Reduced mortality after allogeneic hematopoietic-cell transplantation. N Engl J Med. 2010 Nov 25;363(22):2091-101. doi: 10.1056/NEJMoa1004383.
Ciurea S, Zhang M, Kanakry C. CNIs versus post-transplant cyclophosphamide-based GVHD prophylaxis in haploidentical transplantation. Blood. 2020;137(4):444-455.
Kanakry CG, Tsai HL, Bolanos-Meade J, Smith BD, Gojo I, Kanakry JA, Kasamon YL, Gladstone DE, Matsui W, Borrello I, Huff CA, Swinnen LJ, Powell JD, Pratz KW, DeZern AE, Showel MM, McDevitt MA, Brodsky RA, Levis MJ, Ambinder RF, Fuchs EJ, Rosner GL, Jones RJ, Luznik L. Single-agent GVHD prophylaxis with posttransplantation cyclophosphamide after myeloablative, HLA-matched BMT for AML, ALL, and MDS. Blood. 2014 Dec 11;124(25):3817-27. doi: 10.1182/blood-2014-07-587477. Epub 2014 Oct 14.
Bolanos-Meade J, Hamadani M, Wu J, Al Malki MM, Martens MJ, Runaas L, Elmariah H, Rezvani AR, Gooptu M, Larkin KT, Shaffer BC, El Jurdi N, Loren AW, Solh M, Hall AC, Alousi AM, Jamy OH, Perales MA, Yao JM, Applegate K, Bhatt AS, Kean LS, Efebera YA, Reshef R, Clark W, DiFronzo NL, Leifer E, Horowitz MM, Jones RJ, Holtan SG; BMT CTN 1703 Investigators. Post-Transplantation Cyclophosphamide-Based Graft-versus-Host Disease Prophylaxis. N Engl J Med. 2023 Jun 22;388(25):2338-2348. doi: 10.1056/NEJMoa2215943.
Luznik L, O'Donnell PV, Fuchs EJ. Post-transplantation cyclophosphamide for tolerance induction in HLA-haploidentical bone marrow transplantation. Semin Oncol. 2012 Dec;39(6):683-93. doi: 10.1053/j.seminoncol.2012.09.005.
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Baron F, Labopin M, Blaise D. Reduced-intensity conditioning versus myeloablative conditioning allogeneic hematopoietic stem cell transplantation in acute myeloid leukemia: A study from the Acute Leukemia Working Party of the EBMT. Blood. 2017;129(4):448-456.
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Other Identifiers
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Pro2025-0254
Identifier Type: OTHER
Identifier Source: secondary_id
FLU-TBI-800-PTCY
Identifier Type: -
Identifier Source: org_study_id