To Study Lower Dose of Cyclophosphamide After Stem Cell Transplant for Blood Cancers

NCT07719946 | Recruiting Phase 2 DMC

• 1 other identifier: 901052
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Haploidentical Hematopoietic Stem Cell Transplant; Hematological Malignancies

Keywords

Low dose cyclosphosphamide

Outcome Measures

Primary Outcomes (1)

• Severe (Grade 3-4) aGvHD

  To evaluate the cumulative incidence of severe (Grade 3-4) aGvHD

  at day 100 Post Transplant

Secondary Outcomes (9)

• Cumulative incidence of clinically significant (Grade 2-4) acute graft-versus-host disease (aGvHD)

  Day 100 and Day 180 post-transplant

• Cumulative incidence of severe (Grade 3-4) acute graft-versus-host disease (aGvHD)

  Day 180 post-transplant

• Graft-versus-host disease and relapse-free survival (GRFS)

  1 year post-transplant

• Incidence of chronic graft-versus-host disease (cGvHD

  1 year post-transplant

• Neutrophil engraftment

  Up to Day 100 post-transplant

Study Arms (1)

Low dose cyclosphosphamide

EXPERIMENTAL

Single Arm study and cyclophosphamide at a lower dose (25 mg/kg x 2 days)

Drug: Cyclophosphamide

Interventions

Cyclophosphamide DRUG

Post-transplant Immunosuppression: ● GvHD prophylaxis regimen will consist of two doses of cyclophosphamide on D+3 and D+4 at 25mg/kg/day (that is half of the usual standard dose) with calcineurin inhibitor and mycophenolate mofetil / mycophenolate sodium. Mesna will be given with cyclophosphamide (this is standard of care). The use of calcineurin inhibitors and mycophenolate mofetil / mycophenolate sodium will be as per standard practice. Administration of study treatments * Hydration and MESNA * Adequate intravenous hydration with normal saline will be started at least 4 hours prior to cyclophosphamide, and will be continued till 24 hours post completion of 2nd dose of cyclophosphamide as per standard institutional practice. * Mesna will be administered as a continuous infusion starting from Day+3 till 24 hours after the second dose of PTCy. * Cyclophosphamide * Cyclophosphamide would be administered on D+3 and D+4 \[first dose starting between 60 - 72 hrs after stem cell infusion\]

Low dose cyclosphosphamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age ≥ 18 years
• ECOG performance score of 0 or 1

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tata Memorial Centre: lead
• Indian Council of Medical Research: collaborator

Study Sites (2)

Advanced Centre for Treatment, Research and Education in Cancer

Navi Mumbai, Maharashtra, 410210, India

NOT YET RECRUITING

Advanced Centre for Treatment, Research and Education in Cancer

Navi Mumbai, Maharashtra, 410210, India

RECRUITING

Related Publications (26)

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  PMID: 31586477 RESULT

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MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Dr Sachin Punatar, MBBS MD DM medical oncology

CONTACT

09833445041; drsachin_punatar@yahoo.in

Dr.Akanksha Chichra, FNB,,DNB Pediatric oncology

CONTACT

akanksha7@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Medical Oncologist

Model Details: Prospective Phase-2 Single arm, Single Institution clinical trial.

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 22, 2026
• Study Start: March 26, 2025
• Primary Completion (Estimated): November 12, 2028
• Study Completion (Estimated): November 12, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)