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Pentostatin, Cyclophosphamide...

Pentostatin, Cyclophosphamide, and Rituximab Followed By Campath-1H in Patients With Relapsed or Refractory B-Cell CLL

Last Updated: 2023-06-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-14

Study Completion Date

2018-05-06

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as pentostatin, cyclophosphamide, and CAMPATH-1H work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well pentostatin, cyclophosphamide, rituximab, and CAMPATH-1H work in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia.

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Detailed Description

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OBJECTIVES:

Primary

* Determine the objective response rate (complete remission, partial remission \[PR\], or nodular PR) in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL) treated with pentostatin, cyclophosphamide, and rituximab (PCR) followed by CAMPATH-1H .
* Determine the presence of minimal residual disease in patients treated with this regimen who achieve a CR or nPR

Secondary

* Determine the toxicity of this regimen in these patients.
* Determine the overall and progression-free survival of patients treated with this regimen.
* Evaluate the number of patients who after PCR (or during PCR for PD), only achieve a PR, SD, or PD and who subsequently convert to a higher response category after CAMPATH-1H .

Exploratory

* Assess the angiogenic profile (i.e., secretion levels of pro- versus anti-angiogenic molecules) of CLL B cell clones as well as bone marrow angiogenesis (i.e., vascular density by immunohistochemistry) at baseline, after PCR, after CAMPATH-1H, every six months (serum only), and at time of response assessment (marrow).
* Determine the V\_H gene mutation status and CD38 expression of the B-CLL clones at study entry and at the end of the therapy and assess the association between the VH gene mutation status and CD38 expression and clinical outcome.
* Determine surface phenotype (by flow cytometry) and genetic defects (by CLL FISH panel) information on CLL-B cell clones and associate with clinical outcome.
* Monitor the T-cell status by repertoire and flow cytometry analysis to determine the nature and extent of T-cell deficiency induced by the PCR and CAMPATH-1H treatment and assess any association with clinical outcome and toxicities.

Conditions

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Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A (PCR)

Treatment consisted of 6 cycles of pentostatin, cyclophosphamide, and rituximab (PCR) given every 28 days.

Rituximab administered as follows: For the first infusion, all patients receive 100 mg dose (regardless of weight/BSA). For subsequent infusions, all patients receive rituximab 375 mg/m2.

Pentostatin and cyclophosphamide administered as follows: Pentostatin given at 4 mg/m2 either as an IV push or IV over 10-30 minutes in 250 mL NS or D5W on day 1 every 4 weeks of cycles 1-6. Cyclophosphamide given at 600 mg/m2 IV over 30-60 minutes in 250 mL NS on day 1 every 4 weeks of cycle 1-6.

Group Type EXPERIMENTAL

rituximab

Intervention Type BIOLOGICAL

cyclophosphamide

Intervention Type DRUG

pentostatin

Intervention Type DRUG

Arm B (Alemtuzumab: CR, nPR)

Patients who achieved a confirmed CR or nPR, were registered to receive Alemtuzumab (Arm B). When the patient was registered to Arm B, the drug was administered three times a week for four weeks. The dose was 30 mg per dose. A twelve-week treatment-free period had to elapse before CAMPATH-1H began following completion of PCR for Arm B patients

Group Type EXPERIMENTAL

Alemtuzumab

Intervention Type DRUG

Arm C (Alemtuzumab: PR, <PR, PD)

For those patients not achieving a CR or nPR (thus patients either achieved PR, SD, or PD), Alemtuzumab (Arm C) was administered three times a week for eighteen weeks at a dose of 30 mg TIW. For PR, SD and PD patients, the timing of CAMPATH-1H was left to the discretion of the investigator, and treatment could begin earlier but no less than two weeks and no longer than eight weeks after the completion of the last PCR course. Patients determined to have PD during treatment with PCR did not need to complete all 6 cycles of PCR to go on to Arm C, however, completing a minimum of 2 cycles was required.

Group Type EXPERIMENTAL

Alemtuzumab

Intervention Type DRUG

Interventions

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rituximab

Intervention Type BIOLOGICAL

cyclophosphamide

Intervention Type DRUG

pentostatin

Intervention Type DRUG

Alemtuzumab

Intervention Type DRUG

Other Intervention Names

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Rituxan Cytoxan deoxycoformycin Nipent Campath Campath-1H

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following criteria:

* Peripheral blood absolute lymphocyte count greater than 5,000/mm\^3
* Lymphocytosis must comprise small to moderate size lymphocytes with no greater than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically
* Phenotypically characterized CLL defined by the following:

* Predominant population of cells share B-cell antigens with CD5 in the absence of other pan-T-cell markers (CD3 or CD2)
* B cell expresses either kappa or lambda light chains
* Surface immunoglobulin with low cell surface density expression
* Requires chemotherapy, as indicated by any of the following:

* Disease-related symptoms

* Weight loss of 10% or more within the past 6 months
* Extreme fatigue
* Fevers greater than 100.5°F for 2 weeks without evidence of infection
* Night sweats without evidence of infection
* Evidence of progressive marrow failure manifested by the development of or worsening anemia (hemoglobin no greater than 10 g/dL) and/or thrombocytopenia (platelet count no greater than 100,000/mm\^3)
* Massive (i.e., greater than 6 cm below left costal margin) or progressive splenomegaly
* Massive nodes or clusters (i.e., greater than 10 cm in longest diameter) or progressive adenopathy
* Progressive lymphocytosis with an increase of greater than 50% over a 2-month period OR an anticipated doubling time of less than 6 months
* Demonstrated progression after at least 1 course of either an alkylating agent-based or purine nucleoside-based (e.g., fludarabine) regimen OR failed to achieve a meaningful response OR relapsed after prior therapy

* Patients who have relapsed after a pentostatin-based regimen are eligible provided the response was greater than 12 months prior to study entry
* 18 and over
* ECOG Performance Status 0-2
* Bilirubin no greater than 2 mg/dL (unless secondary to tumor, hemolysis, or Gilbert syndrome)
* Creatinine no greater than 2.0 mg/dL
* Creatinine clearance ≥ 30 mL/min
* Negative pregnancy test
* Fertile patients must use 2 methods of effective contraception (including 1 barrier method) for at least 28 days before starting lenalidomide, while participating in the study, and for at least 28 days after discontinuation/stopping lenalidomide
* At least 8 weeks since prior rituximab
* At least 6 weeks since prior chemotherapy
* At least 1 year since prior pentostatin, cyclophosphamide, and rituximab (PCR) therapy

* PCR therapy at least 1 year prior to study entry allowed

Exclusion Criteria

* Bone marrow dysplasia related to prior therapy
* New York Heart Association class III or IV heart failure
* Prior lenalidomide
* Other malignancy within the past 2 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
* Pregnant or nursing
* Concurrent oral or IV antibiotics for active infection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanford J. Kempin, MD

Role: STUDY_CHAIR

Beth Israel Medical Center

Locations

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Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Aurora Presbyterian Hospital

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

Site Status

St. Anthony Central Hospital

Denver, Colorado, United States

Site Status

Presbyterian - St. Luke's Medical Center

Denver, Colorado, United States

Site Status

St. Joseph Hospital

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

CCOP - Colorado Cancer Research Program

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Littleton Adventist Hospital

Littleton, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

St. Mary - Corwin Regional Medical Center

Pueblo, Colorado, United States

Site Status

North Suburban Medical Center

Thornton, Colorado, United States

Site Status

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, United States

Site Status

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Site Status

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, United States

Site Status

Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Lakeland, Florida, United States

Site Status

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Boise, Idaho, United States

Site Status

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Site Status

Hematology and Oncology Associates

Chicago, Illinois, United States

Site Status

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, United States

Site Status

Kellogg Cancer Care Center

Highland Park, Illinois, United States

Site Status

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, United States

Site Status

Provena St. Mary's Regional Cancer Center - Kankakee

Kankakee, Illinois, United States

Site Status

North Shore Oncology and Hematology Associates, Limited - Libertyville

Libertyville, Illinois, United States

Site Status

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

Moline, Illinois, United States

Site Status

Cancer Care and Hematology Specialists of Chicagoland - Niles

Niles, Illinois, United States

Site Status

Swedish-American Regional Cancer Center

Rockford, Illinois, United States

Site Status

Hematology Oncology Associates - Skokie

Skokie, Illinois, United States

Site Status

Elkhart General Hospital

Elkhart, Indiana, United States

Site Status

Howard Community Hospital

Kokomo, Indiana, United States

Site Status

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, United States

Site Status

Saint Joseph Regional Medical Center

Mishawaka, Indiana, United States

Site Status

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, United States

Site Status

Mercy Medical Center - Sioux City

Sioux City, Iowa, United States

Site Status

St. Luke's Regional Medical Center

Sioux City, Iowa, United States

Site Status

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

Site Status

Cancer Center of Kansas-Independence

Independence, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Liberal

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Newton

Newton, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Salina

Salina, Kansas, United States

Site Status