Sapacitabine, Cyclophosphamide, Rituximab for Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma (CLL/SLL) With Deletion (11q22-23)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Cyclacel Pharmaceuticals, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01253460
First received: December 1, 2010
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

The goal of this clinical research study is to learn if sapacitabine given in combination with 2 standard drugs (cyclophosphamide and rituximab) can help to control CLL and SLL. The safety of this drug combination will also be studied.


Condition Intervention Phase
Leukemia
Drug: Cyclophosphamide
Drug: Rituximab
Drug: Sapacitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial of Sapacitabine, Cyclophosphamide, and Rituximab (SCR) for Relapsed Patients With Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL) and Deletion 11q22-23 by FISH

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]
    Patients evaluated for response by 2008 International Workshop on Chronic Lymphocytic Leukemia [IWCLL] overall response criteria before course 4, then after every 2 courses, and at end of treatment (2 months after last course).


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cyclophosphamide, Rituximab + Sapacitabine
After Sapacitabine 350 mg orally Days 1-3, Cyclophosphamide 250 mg/m2 IV 2 hours, followed by Rituximab 375 mg/m2 IV Day 3, Course 1, and 500 mg/m2 Day 1, subsequent courses.
Drug: Cyclophosphamide
250 mg/m2 by vein (IV) over 30 minutes, 2 hours following the dose of Sapacitabine on days 1, 2, and 3 of each 28 day course.
Other Names:
  • Cytoxan
  • Neosar
Drug: Rituximab
375 mg/m2 by vein over 6 - 8 hours on day 3 of course 1 after cyclophosphamide, then at 500 mg/m2 on day 1, after cyclophosphamide for subsequent courses. Each course is 28 days.
Other Name: Rituxan
Drug: Sapacitabine
350 mg flat dose by mouth in the morning of days 1,2, and 3 of each 28 day course.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have a diagnosis of CLL/SLL and be previously treated
  2. Patients must have had FISH evaluation of leukemia cells within 3 months without intervening treatment demonstrating deletion 11q22-23
  3. Patients must have an indication for treatment by 2008 IWCLL Criteria
  4. Age >/= 18 years
  5. ECOG/Zubrod performance status </= 2
  6. Adequate renal and hepatic function as indicated by all the following: serum creatinine </= 2 mg/dL AND; alanine aminotransferase (ALT) </= 2.5 times upper limit of normal; AND total bilirubin </= 2.5 times upper limit of normal
  7. Patients must have an ANC >/= 500/uL, HGB >/= 8 gm/dL, PLT count >/= 20K/uL, unless attributed to marrow infiltration with CLL
  8. Patients must give written informed consent
  9. Patients of childbearing potential (females who have not been postmenopausal for at least 12 consecutive months or who have not undergone previous surgical sterilization or males who have not been surgically sterilized) must be willing to practice birth control during the study

Exclusion Criteria:

  1. Pregnant or breast-feeding females
  2. Significant co-morbidity indicated by major organ system dysfunction
  3. Active infection, uncontrolled with intravenous antibiotics
  4. Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenia purpura (ITP)
  5. Treatment including chemotherapy, chemoimmunotherapy, monoclonal antibody therapy, radiotherapy, high-dose corticosteroid therapy (prednisone >/= 60 mg daily, or equivalent), or immunotherapy within 3 weeks prior to enrollment or concurrent with this trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253460

Contacts
Contact: William G. Wierda, MD,PHD,BS 713-745-0428

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: William G. Wierda, MD, PHD, BS         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Cyclacel Pharmaceuticals, Inc.
Investigators
Principal Investigator: William G. Wierda, MD, PHD, BS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01253460     History of Changes
Other Study ID Numbers: 2010-0516, NCI-2011-00119
Study First Received: December 1, 2010
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Chronic Lymphocytic Leukemia
CLL
Small Lymphocytic Lymphoma
SLL
Cyclophosphamide
Rituximab
Sapacitabine
Cytoxan
Neosar
Rituxan

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Rituximab
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014