Donor Stem Cell Transplant in Treating Patients With High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT01027000
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
  • busulfan — DRUG
  • cyclophosphamide — DRUG
  • fludarabine phosphate — DRUG
  • methotrexate — DRUG
  • sirolimus — DRUG
  • tacrolimus — DRUG
  • allogeneic stem cell transplant — PROCEDURE

Study Details

RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as rituximab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, and methotrexate after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma.

Key Dates

Start date
Feb 28, 2010
Status verified
Apr 2023
Primary completion
Jan 31, 2016
Completion
Apr 30, 2023

Study Design

Enrollment
68 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Combination of chemotherapy and transplant)
    See detailed description

Primary Outcome Measure

2-year Progression-free Survival in Early Disease Participants [ Time Frame: 2 years post-registration ]

Locations (25)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-3000-
Tunnell Cancer Center at Beebe Medical CenterLewesDelaware19958-
CCOP - Christiana Care Health ServicesNewarkDelaware19713-
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlandoFlorida32803-1273-
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampaFlorida33612-9497-
University of Chicago Cancer Research CenterChicagoIllinois60637-1470-
Holden Comprehensive Cancer Center at University of IowaIowa CityIowa52242-1002-
Union Hospital of Cecil CountyElktonMaryland21921-
Dana-Farber/Brigham and Women's Cancer CenterBostonMassachusetts02115-
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt LouisMissouri63110-
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmahaNebraska68198-6805-
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees TownshipNew Jersey08043-
Roswell Park Cancer InstituteBuffaloNew York14263-0001-
Monter Cancer Center of the North Shore-LIJ Health SystemLake SuccessNew York11042-
CCOP - North Shore University HospitalManhassetNew York11030-
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhassetNew York11030-
Long Island Jewish Medical CenterNew Hyde ParkNew York11040-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
New York Weill Cornell Cancer Center at Cornell UniversityNew YorkNew York10021-
Wake Forest University Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-1096-
Cleveland Clinic Taussig Cancer CenterClevelandOhio44195-
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbusOhio43210-1240-
Oklahoma University Cancer InstituteOklahoma CityOklahoma73104-

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope Comprehensive Cancer Center· Duarte, CATunnell Cancer Center at Beebe Medical Center· Lewes, DECCOP - Christiana Care Health Services· Newark, DEFlorida Hospital Cancer Institute at Florida Hospital Orlando· Orlando, FLH. Lee Moffitt Cancer Center and Research Institute at University of South Florida· Tampa, FLUniversity of Chicago Cancer Research Center· Chicago, IL

Related Studies