Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation

NCT01283776 | Completed Phase 2

• 1 other identifier: Uni-Koeln-1430
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of patients not requiring additional immunosuppression

  The primary endpoint is met if at least 1 of the 5 first patients and 3 of a total of 11 patient will reach day 100 after transplant without additional immunsuppressive drug treatment

  day 100 after transplant

Secondary Outcomes (7)

• Overall Survival

  day 100 after transplant

• engraftment

  day 100 after transplant

• chimerism

  day 100 after transplant

• relapse incidence

  day 100 after transplant

• acute GvHD

  day 100 after transplant

Study Arms (1)

treatment arm

EXPERIMENTAL

Cyclophosphamide

Drug: Cyclophosphamide

Interventions

Cyclophosphamide DRUG

100 mg/kg total dose, infused on day +3 and +3 after allogeneic stem cell transplantation

treatment arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University of Cologne

Cologne, 50924, Germany

Location

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin; Hodgkin Disease

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Lymphatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Christoph Scheid, MD PhD

  University of Cologne

  PRINCIPAL INVESTIGATOR

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: PD Dr. Christoph Scheid

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: January 26, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: June 10, 2014

Record last verified: 2014-06

Locations

DE (1)