Clinical trial · Interventional
To Study Lower Dose of Cyclophosphamide After Stem Cell Transplant for Blood Cancers
Phase II Trial of Reduced Dose Post Transplant Cyclophosphamide After Haploidentical Hematopoietic Stem Cell Transplant in Hematological Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cyclophosphamide is the name of a medicine given to prevent graft-versus-host-disease (GVHD) after half-matched transplant. This medicine is given on the 3rd and 4th day after stem cell transplant. The standard dose of this medicine is 50 mg per kg of the patient's weight given on the 3rd and the 4th day. However, using this medicine at this dose of 50 mg / kg for 2 days is associated with certain problems such as susceptibility to infections and delay in the recovery of the immune system after stem cell transplant. Therefore, several research groups across the world have tried to reduce the dose of cyclophosphamide that is used. These groups have tried reducing the dose from 50 mg per kg to 25-40 mg per kg. These studies have shown that the reduced dose cyclophosphamide is equally effective in preventing GVHD. However, these studies are carried out on small numbers of patients and further studies are essential to confirm whether reduced dose of cyclophosphamide is equally effective. In this study, we will use cyclophosphamide at a lower dose (25 mg/kg x 2 days) and see if the lower dose results in equal efficacy but lesser toxicities This is a single-arm study. All participants will receive the same treatment; there is no comparison group. Participants will: Adults (age ≥18) undergoing haploidentical stem cell transplant for blood cancers Receive low-dose cyclophosphamide (25 mg/kg/day) on Day 3 and Day 4 after transplant Also receive standard GVHD preventive medicines (calcineurin inhibitor and mycophenolate) Undergo regular blood tests, immune system monitoring, and GVHD assessments Have immune cell and cytokine profiles analyzed through blood samples
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Haploidentical Hematopoietic Stem Cell Transplant | — | UNRESOLVED | — |
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Low dose cyclosphosphamide
- description
- Single Arm study and cyclophosphamide at a lower dose (25 mg/kg x 2 days)
- interventionNames
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- Severe (Grade 3-4) aGvHD
- timeFrame
- at day 100 Post Transplant
- description
- To evaluate the cumulative incidence of severe (Grade 3-4) aGvHD
Secondary outcomes (9)
- measure
- Cumulative incidence of clinically significant (Grade 2-4) acute graft-versus-host disease (aGvHD)
- timeFrame
- Day 100 and Day 180 post-transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: - * Patients age ≥ 18 years * ECOG performance score of 0 or 1 Exclusion Criteria: - * Presence of an active uncontrolled infection defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. * Any medical or psychiatric illness which precludes the participant from giving informed consent. * Organ function criteria: Serious organ dysfunctions: * Serious cardiac dysfunction: Left ventricular ejection fraction \< 45%; no uncontrolled arrhythmias or symptomatic cardiac disease. * Serious pulmonary organ dysfunction: Symptomatic pulmonary disease; forced expiratory volume in one second (FEV1), forced vital capacity (FVC), diffusion capacity of the lung for carbon monoxide (DLCO) =\< 50% of predicted (corrected for haemoglobin). * Serious renal dysfunction: Measured serum creatinine clearance =\< 60 mL/min. * Serious Hepatic dysfunction: Total serum bilirubin more than twice upper normal limit or Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3-fold higher than laboratory upper normal limits.
References
Publications (26)
- RESULTSugita J, Kamimura T, Ishikawa T, Ota S, Eto T, Kuroha T, Miyazaki Y, Kumagai H, Matsuo K, Akashi K, Taniguchi S, Harada M, Teshima T. Reduced dose of posttransplant cyclophosphamide in HLA-haploidentical peripheral blood stem cell transplantation. Bone Marrow Transplant. 2021 Mar;56(3):596-604. doi: 10.1038/s41409-020-01065-0. Epub 2020 Sep 24. PMID 32973350
- RESULTNakamae H, Koh H, Katayama T, Nishimoto M, Hayashi Y, Nakashima Y, Nakane T, Nakamae M, Hirose A, Hino M. HLA haploidentical peripheral blood stem cell transplantation using reduced dose of posttransplantation cyclophosphamide for poor-prognosis or refractory leukemia and myelodysplastic syndrome. Exp Hematol. 2015 Nov;43(11):921-929.e1. doi: 10.1016/j.exphem.2015.07.006. Epub 2015 Aug 15. PMID 26284307
- RESULTMeredith J. McAdams, Dimana Dimitrova, Jennifer L. Sadler, Seth M. Steinberg, Jennifer Cuellar-Rodriguez, Thomas E. Hughes, Nuri Cha, Ellen B. Carroll, Stephanie N. Hicks, Amy Chai, Scott Napier, Anita Stokes, Richard Kwan, Jennifer Sponaugle, Mustafa Hyder, Ronald E. Gress, Jennifer A. Kanakry, Chris G. Kanakry. Phase I Study De-Intensifying Exposure of Post Transplantation Cyclophosphamide (PTCy) after HLA Haploidentical Hematopoietic Cell Transplantation (HCT) for Hematologic Malignancies. Transplant Cell Ther 27 3S (2021) S1-S488.
- RESULTWachsmuth LP, Patterson MT, Eckhaus MA, Venzon DJ, Kanakry CG. Optimized Timing of Post-Transplantation Cyclophosphamide in MHC-Haploidentical Murine Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2020 Feb;26(2):230-241. doi: 10.1016/j.bbmt.2019.09.030. Epub 2019 Oct 2. PMID 31586477
- RESULTGoldsmith SR, Abid MB, Auletta JJ, Bashey A, Beitinjaneh A, Castillo P, Chemaly RF, Chen M, Ciurea S, Dandoy CE, Diaz MA, Fuchs E, Ganguly S, Kanakry CG, Kanakry JA, Kim S, Komanduri KV, Krem MM, Lazarus HM, Liu H, Ljungman P, Masiarz R, Mulroney C, Nathan S, Nishihori T, Page KM, Perales MA, Taplitz R, Romee R, Riches M. Posttransplant cyclophosphamide is associated with increased cytomegalovirus infection: a CIBMTR analysis. Blood. 2021 Jun 10;137(23):3291-3305. doi: 10.1182/blood.2020009362.