Clinical trial · Interventional

S0902 Bendamustine and Rituximab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia That Has Not Responded to Previous Treatment

S0902, Phase II Study of Bendamustine Plus Rituximab for the Treatment of Refractory B-Cell Chronic Lymphocytic Leukemia

NCT00939328CI-TRIAL-00017048withdrawnPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): question was no longer committee priority

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Giving bendamustine together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects of giving bendamustine together with rituximab and to see how well it works in treating patients with B-cell chronic lymphocytic leukemia that has not responded to previous treatment.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
bendamustine hydrochloride	Drug	Bendamustine	ALIAS
rituximab	Biological	Rituximab	ALIAS

Design

Arms and outcomes

Arms (0)

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Primary outcomes (2)

measure
Response rate (CR, CRi, or PR)
measure
Safety and tolerability

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically and immunophenotypically confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL)

  * Progressive or symptomatic disease
  * Purine analog-refractory disease
* Must meet 1 of the following criteria:

  * Intermediate- or high-risk modified-Rai stage
  * Low-risk modified-Rai stage and progressive lymphocytosis, defined as \> 50% increase of absolute peripheral lymphocyte count over the lowest count during the past 2 months
* Received 1 or more prior therapies for CLL
* Must be registered on SWOG-9007, "Cytogenetic Studies in Leukemia Patients"

PATIENT CHARACTERISTICS:

* Zubrod performance status 0-3
* ANC \> 1,000/mm³
* Platelet count \> 50,000/mm³
* Serum creatinine ≤ 2 times upper limit of normal (ULN) OR creatinine clearance ≥ 50 mL/min
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No systemic fungal, bacterial, viral, or other infection that is not controlled (i.e., exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
* No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for 5 years
* HIV positivity allowed provided the following criteria are met:

  * CD4 cells \> 350/mm³
  * No concurrent antiretroviral therapy

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* More than 28 days since prior chemotherapy, any other investigational agents, or major surgery
* More than 120 days since prior allogeneic or autologous hematopoietic stem cell transplantation

  * If prior allogeneic bone marrow transplantation, must meet the following criteria:

    * Performed \> 120 days ago
    * No acute graft-vs-host disease (GVHD) ≥ grade 2
    * Receiving no immunosuppressive therapy for chronic GVHD
* No concurrent antiretroviral therapy for HIV-positive patients
* No concurrent CYP1A2 inhibitors

References

Publications (0)

Data not yet available

No reference posted for this study.