Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation (OCTET-CY)

University of Cologne

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma; Hodgkin's Disease; Non-Hodgkin-Lymphoma

Treatments: Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT01283776

Uni-Koeln-1430

Details and patient eligibility

About

A phase II clinical study to assess the efficacy of post-transplantation cyclophosphamide as single-agent GvHD prophylaxis after allogeneic hematopoietic stem cell transplantation in patients with multiple myeloma or lymphoma and to describe the influence of the modified immunosuppression concept on relapse rates, minimal residual disease, immune reconstitution and chimerism.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with multiple myeloma, Non-Hodgkin's lymphoma or Hodgkin's disease after allogeneic stem cell transplantation with reduced intensity conditioning

  • Written informed consent
  • No uncontrolled infections

Exclusion criteria

• Severe organ dysfunction defined as:
• Cardiac left ventricular ejection fraction (LVEF) of less than 35%
• diffusing lung capacity (DLCO) of less than 40%
• total lung capacity (TLC) of less than 40%
• forced expiratory volume (FEV1) of less than 40%
• total bilirubin >3mg/dl
• creatinine-clearance of less than 40 ml/min
• pregnancy or breast feeding
• participation in other experimental drug trials

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

11 participants in 1 patient group

treatment arm

Experimental group

Description:

Cyclophosphamide

Treatment:

Drug: Cyclophosphamide