This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study is ongoing, but not recruiting participants.
Cyclacel Pharmaceuticals, Inc.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: December 1, 2010
Last updated: December 15, 2016
Last verified: December 2016
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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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).

Enrollment: 19
Study Start Date: July 2011
Estimated Primary Completion Date: July 2019 (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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01253460

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Cyclacel Pharmaceuticals, Inc.
National Cancer Institute (NCI)
Principal Investigator: William G. Wierda, MD, PHD, BS M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01253460     History of Changes
Other Study ID Numbers: 2010-0516
NCI-2011-00119 ( Registry Identifier: NCI CTRP )
5P01CA081534 ( U.S. NIH Grant/Contract )
Study First Received: December 1, 2010
Last Updated: December 15, 2016

Keywords provided by M.D. Anderson Cancer Center:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists processed this record on September 21, 2017