NCT01315132

Brief Summary

This research study uses a drug called cyclophosphamide to decrease the incidence of GVHD in matched sibling hematopoietic stem cell transplant. In doing so, the goal of the study is to increase overall survival.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2008

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2019

Completed
2 months until next milestone

Results Posted

Study results publicly available

October 15, 2019

Completed
Last Updated

March 19, 2026

Status Verified

February 1, 2026

Enrollment Period

10.4 years

First QC Date

March 11, 2011

Results QC Date

September 4, 2019

Last Update Submit

February 27, 2026

Conditions

Hematological MalignanciesLeukemiaLymphomaMultiple MyelomaHodgkin's Disease

Keywords

Myeloablative Hematopoietic Stem Cell TransplantCyclophosphamide tolerization2 Step ApproachHematological malignanciesleukemialymphomamultiple myelomaHodgkin's Disease

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Overall Survival

    The primary objective of this prospective, phase II trial was to obtain an OS rate of \>60% at 1 year in patients undergoing a 2 step HSCT from an HLA compatible family donor. The \>60% threshold was selected as a composite efficacy measure as patients with any hematologic diagnosis, stage of disease, or age as old as 65 years were eligible for this treatment protocol.

    1 Year after transplant

Secondary Outcomes (1)

  • Graft Versus Host Disease (GVHD)

    1 Year after transplant

Study Arms (1)

Allogeneic Transplantation

EXPERIMENTAL

Matched Sibling Allogeneic Transplantation

Device: Matched Sibling Allogeneic Transplantation

Interventions

Matched Sibling Allogeneic TransplantationDEVICE

Patients undergoing myeloablative hematopoietic stem cell transplant from HLA identical related donors using cyclophosphamide tolerization

Also known as: CliniMACS
Allogeneic Transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient with a hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied. Patients will be considered high-risk if they have any of the following:
  • Age \> 50 years
  • ECOG Performance status of \<2
  • Acute leukemia: requiring more than one chemotherapy regimen to obtain 1st CR; second or greater CR, 1st relapse; any ph+ ALL
  • CML 2nd chronic phase, accelerated phase, or blastic phase
  • MDS with IPS of Intermediate 2 or greater
  • Any myeloproliferative disorder
  • Hodgkin lymphoma: relapsed, refractory, or primary induction failure
  • Non-Hodgkin lymphoma: relapsed, refractory, primary treatment failure, or not eligible for an autologous HSCT
  • Other conditions not listed will be assessed as high-risk by the PI
  • Patients must have a related donor who is either HLA-identical or a one antigen mismatch at the HLA- A; B; C; and DR loci.
  • Patients must adequate organ function:
  • LVEF of \>45%
  • DLCO (adjusted for hemoglobin) \>45% of predicted
  • Adequate liver function as defined by a serum bilirubin \<1.8, AST or ALT \< 2.5X upper limit of normal
  • +3 more criteria

You may not qualify if:

  • ECOG performance status of 3 or 4.
  • HIV positive
  • Active involvement of the central nervous system with malignancy
  • Psychiatric disorder that would preclude patients from signing an informed consent
  • Pregnancy
  • Patients with life expectancy of \< 6 months for reasons other than their underlying hematologic/oncologic disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

MeSH Terms

Conditions

Hematologic NeoplasmsLeukemiaLymphomaMultiple MyelomaHodgkin Disease

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Results Point of Contact

Title
Neal Flomenberg, MD
Organization
Sidney Kimmel Cancer Center at Thomas Jefferson University
Neal.Flomenberg@jefferson.edu
215-955-4367

Study Officials

  • Neal Flomenberg, MD

    Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 15, 2011

Study Start

April 10, 2008

Primary Completion

September 19, 2018

Study Completion

August 29, 2019

Last Updated

March 19, 2026

Results First Posted

October 15, 2019

Record last verified: 2026-02

Locations

US(1)