Reduced Intensity Haploidentical Transplant for Hematological Malignancies

NCT01162096 | Completed Phase 1 Results DMC

• 3 other identifiers: 06U.3282006-29JT 1149
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Many patients with hematological malignancies (leukemia, lymphoma, multiple myeloma) cannot undergo hematopoietic stem cell transplantation (HSCT) because they do not have a well matched donor. HSCT from partially matched family donors (haploidentical HSCT) is an option for most patients but has been associated with poor outcomes. This study was designed to test whether using an exact amount of a donor's lymphocytes (white cells) and dividing the transplant process into 2 steps, would increase overall survival by decreasing complications. The therapy is reduced intensity so it is targeted, but not limited to, patients over the age of 65 or those who have had previous transplants.

Conditions

Hematological Malignancies

Keywords

Reduced Intensity Haploidentical Transplant

Outcome Measures

Primary Outcomes (1)

• Overall Survival at 6 Months Post-transplant in Patients Receiving a Partially-matched Related Donor Allogeneic Transplant After Reduced-intensity Conditioning

  Number of patients alive at 6 months post-transplant

  6 months

Secondary Outcomes (2)

• Number of Participants With Successful Engraftment

  6 months

• Immune Reconstitution

  Up to 5 years

Study Arms (1)

Transplantation

EXPERIMENTAL

Device: Haploidentical Allogeneic Transplantation

Interventions

Haploidentical Allogeneic Transplantation DEVICE

Patients undergoing reduced intensity haploidentical hematopoietic stem cell transplant from a partially matched related donor.

Also known as: CliniMACS

Transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 must have a related donor who is a two or more allele mismatch at the HLA-A;B; C; DR loci.
• Patients who have sibling donors with a one antigen mismatch due to recombination will not be enrolled in this protocol.
• Patients must adequate organ function:
• LVEF of \>45%
• DLCO \>45% of predicted corrected for hemoglobin
• Adequate liver function as defined by a serum bilirubin \<1.8, AST or ALT \< 2.5X upper limit of normal
• Serum creatinine \< 2.0 mg/dl or creatinine clearance of \> 40 ml/min
• Performance status \> 70% (Karnofsky)
• Patients must be willing to use contraception if they have childbearing potential
• Able to give informed consent

You may not qualify if:

• Performance status of \< 70% (Karnofsky)
• 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 or complications there from.
• Patients who have received alemtuzumab within 8 weeks of transplant admission, or who have recently received horse or rabbit anti-thymocyte globulin and have ATG levels of \> 2 µgm/ml.
• Patients who cannot receive cyclophosphamide
• Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center
• Thomas Jefferson University Hospitals

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Neal Flomenberg, MD
• Organization: Thomas Jefferson University

neal.flomenberg@jefferson.edu

215-955-4367

Study Officials

• Neal Flomenberg, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2010
• First Posted: July 14, 2010
• Study Start: September 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: April 1, 2012
• Last Updated: April 30, 2025
• Results First Posted: January 15, 2015

Record last verified: 2025-04

Locations

US (1)