Mode
Text Size
Log in / Sign up
Phase 2 N=68 Treatment

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

Leukemia · Lymphoma

Enrolled (actual)
68
Serious AEs
10.2%
Results posted
May 2017
Primary outcome: Primary: 2-year Progression-free Survival in Early Disease Participants — 79.5 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
rituximab (Biological); busulfan (Drug); cyclophosphamide (Drug); fludarabine phosphate (Drug); methotrexate (Drug); sirolimus (Drug); tacrolimus (Drug); allogeneic stem cell transplant (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Alliance for Clinical Trials in Oncology
Primary completion
Jan 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
2-year Progression-free Survival in Early Disease Participants
79.5
SECONDARY
Response
SECONDARY
Acute Graft-vs-host Disease (GVHD)
SECONDARY
Chronic GVHD
SECONDARY
Treatment-related Mortality
SECONDARY
Overall Survival
SECONDARY
Chimerism for CD3

Summary

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.

Eligibility Criteria

Patient Eligibility:

  • Diagnosis of B-cell chronic lymphocytic leukemia or B-cell small lymphocytic lymphoma.

Diagnosis should be according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria

  • Early Disease Cohort - Patients in the early disease cohort must include one or more of the following:
  • FISH showing deletion 17p in ≥ 20% of cells (either at diagnosis or any time prior to study entry) either alone or in combination with other cytogenetic abnormalities
  • FISH showing del 11q in ≥ 20% of cells (either at diagnosis or any time prior to study entry) either alone or in combination with other cytogenetic abnormalities, unless the patient has achieved a complete remission by IWCLL 2008 which includes CT scan, bone marrow morphology and flow cytometry
  • Failure to achieve a partial response with initial chemotherapy, but with lack of progression. These patients may receive a second therapy to improve their response prior to transplant.
  • Patients who, at the time of first progression, have a 17p deletion by FISH in ≥ 20% of cells, either alone or in combination with other cytogenetic abnormalities.

The duration of the first progression is not specified.

  • In addition, patients in the early disease cohort must have all of the following:
  • Received at least 2 cycles of induction therapy. It is expected that most patients will receive at least 4 months of therapy prior to enrollment, but this is not required. Suggested regimens include but are not limited to the following: fludarabine plus rituximab, fludarabine, cyclophosphamide plus rituximab, pentostatin, cyclophosphamide plus rituximab, bendumustine plus rituximab, or alemtuzumab alone or in combination with other agents. Patients may receive no more than 2 different regimens prior to proceeding to transplantation.
  • Nodes ≤ 5 cm
  • Advanced Disease Cohort - Patients in the advanced disease cohort must include one or more of the following:
  • FISH showing deletion 17p in ≥ 20% of cells (regardless of interval from initial therapy) either alone or in combination with other cytogenetic abnormalities
  • First progression < 24 months after completing therapy. This includes progression on initial therapy.
  • Second or subsequent progression
  • In addition, patients in the advanced disease cohort must have all of the following:
  • Stable disease or better by the Revised IWCLL 2008 NCI Criteria to their most recent chemotherapy
  • Nodes ≤ 5 cm
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Age Requirement - Patients must be between ≥ 18 and < 70 years of age
  • Cytotoxic Chemotherapy or Alemtuzamab - There must be at least 4 weeks after day 1 of the last cycle of cytotoxic chemotherapy, or alemtuzamab.
  • Human Immunodeficiency Virus (HIV) Status - Patients must have no HIV infection.

Allogeneic transplantation in the HIV patient population is not well-defined and there are likely to be requirements for concomitant anti-HIV therapy and anti-GVHD therapy that would create potentially dangerous pharmacokinetic interactions among the different agents that could constrain therapeutic options for controlling both HIV and GVHD.

  • Hepatitis B and C - Patients must have no Hepatitis B sAg, anti-HBc or HCV.
  • Diffusion capacity of carbon monoxide DLCO must be ≥ 40% predicted
  • Left ventricular ejection fraction (LVEF) by Echocardiogram (ECHO) or Multiple gated acquisition (MUGA) must be ≥ 30%
  • Diabetes or Serious Infection - Patients must have no uncontrolled diabetes mellitus or active uncontrolled serious infections
  • Pregnancy and Nursing Status - Patients must be non-pregnant and non-nursing. Treatment under this protocol would expose a fetus to significant risks. Women of childbearing potential should have a negative pregnancy test prior to study entry.

Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic pote

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01027000). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search