Lower Dose Cyclophosphamide After Haploidentical Stem Cell Transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this phase 2 study, adults undergoing haploidentical hematopoietic stem cell transplant for blood cancers receive cyclophosphamide at 25 mg/kg on days +3 and +4, followed by standard immunosuppression. The goal is to see if the reduced dose can prevent graft-versus-host disease as effectively as the standard dose while potentially improving engraftment and immune recovery. The trial is designed to assess safety and efficacy in a prospective, multi-center setting. Participants are monitored for GVHD, engraftment timing, immune reconstitution, infections, and organ toxicity. Positive results could support a phase 3 trial and influence practice for haploidentical transplants.

Why it matters

Who can join: the full rules

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.

Where it's running

• Advanced Centre for Treatment, Research and Education in Cancer
  Navi Mumbai, Maharashtra, India Recruiting
• Advanced Centre for Treatment, Research and Education in Cancer
  Navi Mumbai, Maharashtra, India Not yet recruiting

Study contacts

• Study coordinator: Dr Sachin Punatar, MBBS MD DM medical oncology
• Email: drsachin_punatar@yahoo.in
• Phone: 09833445041

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.