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

NCT01253460 | Terminated Phase 2 Results FDA Drug

• 3 other identifiers: 2010-0516NCI-2011-001195P01CA081534
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia

Keywords

Chronic Lymphocytic Leukemia; CLL; Small Lymphocytic Lymphoma; SLL; Cyclophosphamide; Rituximab; Sapacitabine; Cytoxan; Neosar; Rituxan

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  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). Overall Response Rate (ORR) = Complete Response (CR) + Partial Response (PR). Complete response is the absence of signs and symptoms, normalization of peripheral blood and bone marrow and lymph nodes 1.5 cm in diameter or smaller on CT scan. Partial response is at least 50% reduction in disease signs and symptoms, a 50% improvement in peripheral blood and greater than or equal to 50% reduction in lymph nodes.

  84 days

Secondary Outcomes (1)

• Overall Survival

  Up to 8.5 years

Study Arms (1)

Cyclophosphamide, Rituximab + Sapacitabine

EXPERIMENTAL

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; Drug: Rituximab; Drug: Sapacitabine

Interventions

Cyclophosphamide DRUG

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.

Also known as: Cytoxan, Neosar

Cyclophosphamide, Rituximab + Sapacitabine

Rituximab DRUG

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.

Also known as: Rituxan

Cyclophosphamide, Rituximab + Sapacitabine

Sapacitabine DRUG

350 mg flat dose by mouth in the morning of days 1,2, and 3 of each 28 day course.

Cyclophosphamide, Rituximab + Sapacitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a diagnosis of CLL/SLL and be previously treated
• Patients must have had Fluorescence in situ Hybridization (FISH) evaluation of leukemia cells within 3 months without intervening treatment demonstrating deletion 11q22-23
• Patients must have an indication for treatment by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria
• Age \>/= 18 years
• Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status \</= 2
• 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
• Patients must have an Absolute neutrophil count (ANC) \>/= 500/uL, Hemoglobin (HGB) \>/= 8 gm/dL, Platelets (PLT) count \>/= 20K/uL, unless attributed to marrow infiltration with CLL
• Patients must give written informed consent
• 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

You may not qualify if:

• Pregnant or breast-feeding females
• Significant co-morbidity indicated by major organ system dysfunction
• Active infection, uncontrolled with intravenous antibiotics
• Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenia purpura (ITP)
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Cyclacel Pharmaceuticals, Inc.: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Cyclophosphamide; Rituximab; sapacitabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: William G Wierda, MD/Professor
• Organization: The University of Texas MD Anderson Cancer Center

wwierda@mdanderson.org

713-745-0428

Study Officials

• William G. Wierda, MD, PHD, BS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 3, 2010
• Study Start: August 22, 2011
• Primary Completion: March 28, 2018
• Study Completion: February 13, 2019
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-08

Locations

US (1)