Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving cytarabine together with clofarabine works in treating patients with relapsed or refractory acute lymphoblastic leukemia.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2 leukemia

Timeline

Completed

Started Oct 2006

Typical duration for phase_2 leukemia

Geographic Reach

1 country

91 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.3 years study duration

First Submitted

Initial submission to the registry

June 13, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2006

Completed

4 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed

3.6 years until next milestone

Results Posted

Study results publicly available

July 10, 2012

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed

Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

2.2 years

First QC Date

June 13, 2006

Results QC Date

June 5, 2012

Last Update Submit

March 5, 2015

Conditions

Leukemia

Keywords

recurrent adult acute lymphoblastic leukemiaL1 adult acute lymphoblastic leukemiaL2 adult acute lymphoblastic leukemiaB-cell adult acute lymphoblastic leukemiaT-cell adult acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

Number of Patients With Complete Remission
Complete remission is defined as: less than 5% bone marrow blasts, neutrophils greater or equal to 1,000 per microliter, platelets greater than 100,000 per microliter, no blasts in the peripheral blood, and no extramedullary disease
Between day 28 and day 35 inclusive

Secondary Outcomes (3)

Expression of Nucleoside Transporters
On average, two weeks before treatment started
Number of Patients With Very Poor Risk Cytogenetics
On average, 2 weeks before treatment started
Toxicity
Patients were assess for adverse events after each induction cycle (up to two cycles) and after the one consolidation cycle

Study Arms (1)

Induc, ReInduc, Consol, clofarabine, cytarabine

EXPERIMENTAL

Induction: 40mg/m2/d; IV over 1 hr; days 1-5 Re-induction (if necessary): 40mg/m2/d; IV over 1 hr; days 1-5 Consolidation: 40mg/m2/d; IV over 1 hr; days 1-4

Drug: clofarabineDrug: cytarabine

Interventions

clofarabineDRUG

Induction: 40mg/m2/d; IV over 1 hr; days 1-5 Re-induction (if necessary): 40mg/m2/d; IV over 1 hr; days 1-5 Consolidation: 40mg/m2/d; IV over 1 hr; days 1-4

Induc, ReInduc, Consol, clofarabine, cytarabine

cytarabineDRUG

Induction: 1g/m2/d; IV over 2 hrs; days 1-5 Re-induction (if necessary): 1g/m2/d; IV over 2 hrs; days 1-5 Consolidation: 1g/m2/d; IV over 2 hrs; days 1-4

Induc, ReInduc, Consol, clofarabine, cytarabine

Eligibility Criteria

Age16 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Prior morphologic diagnosis of acute lymphoblastic leukemia (ALL) * No M0, mixed lineage, or L3 (Burkitt's) ALL * Refractory to a standard induction regimen OR relapsed after successful prior induction therapy * Standard induction regimen is defined as any program of treatment that includes vincristine and prednisone or high-dose cytarabine/mitoxantrone * Any number of inductions or remissions allowed * Must have evidence of ALL in bone marrow or peripheral blood * Immunophenotyping of the blood or bone marrow lymphoblasts must be performed to determine lineage (B cell, T cell, or mixed B/T cell) * No extramedullary only disease in the absence of bone marrow or blood involvement * Co-expression of myeloid antigens (CD13 and CD33) allowed * Patients with Philadelphia chromosome-positive (Ph+) ALL or bcr/abl-positive ALL who were previously eligible for imatinib mesylate treatment must have received imatinib mesylate either alone or in combination with chemotherapy for ALL and must have either failed treatment or been unable to tolerate treatment * No CNS involvement as determined by lumbar puncture (for previous CNS history or clinical signs or symptoms of CNS) or by clinical exam (if no previous history or signs/symptoms) * Must be registered on SWOG-S9910 and SWOG-9007 PATIENT CHARACTERISTICS: * Zubrod performance status 0-2 * Creatinine ≤ 1.5 times upper limit of normal (ULN) * AST or ALT ≤ 1.5 times ULN * Bilirubin ≤ 1.5 times ULN * No psychiatric disorders that would interfere with study compliance * No uncontrolled systemic fungal, bacterial, viral, or other infection * No other severe concurrent disease * No other serious or poorly controlled medical condition that would preclude study participation * No history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that would preclude study participation * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No pre-existing motor or sensory neuropathy ≥ grade 2 * No other prior malignancies, except for the following: * Adequately treated basal cell or squamous cell skin cancer * In situ cervical cancer * Adequately treated stage I or II cancer in complete remission * Any other prior cancer for which the patient has been disease free for ≥ 5 years PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior therapy * No prior clofarabine * More than 2 weeks since prior chemotherapy, major surgery, or other investigational agents * More than 6 weeks since prior monoclonal antibodies * Prior allogeneic or autologous bone marrow transplant allowed provided the following criteria are met: * More than 90 days since transplant * No acute graft-versus-host disease (GVHD) ≥ grade 2 OR moderate or severe limited chronic GVHD OR extensive chronic GVHD of any severity * Prior maintenance therapy with steroids, vincristine, and/or anti-metabolite agents, such as, but not limited to, mercaptopurine, thioguanine, or methotrexate allowed * Concurrent hydroxyurea allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator

Study Sites (91)

Providence Cancer Center

Anchorage, Alaska, 99508, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Stanford Cancer Center

Stanford, California, 94305-5824, United States

Location

M.D. Anderson Cancer Center at Orlando

Orlando, Florida, 32806, United States

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Northside Hospital Cancer Center

Atlanta, Georgia, 30342-1611, United States

Location

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342-1701, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342, United States

Location

WellStar Cobb Hospital

Austell, Georgia, 30106, United States

Location

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, 30033, United States

Location

Gwinnett Medical Center

Lawrenceville, Georgia, 30045, United States

Location

Kennestone Cancer Center at Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Southern Regional Medical Center

Riverdale, Georgia, 30274-2600, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, 46107, United States

Location

Reid Hospital & Health Care Services

Richmond, Indiana, 47374, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67042, United States

Location

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Tulane Cancer Center Office of Clinical Research

Alexandria, Louisiana, 71315-3198, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare Cancer Care Services

Billings, Montana, 59101, United States

Location

Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Cancer Center

Bozeman, Montana, 59715, United States

Location

St. James Healthcare Cancer Care

Butte, Montana, 59701, United States

Location

Frontier Cancer Center

Great Falls, Montana, 59405, United States

Location

Great Falls Clinic - Main Facility

Great Falls, Montana, 59405, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology, PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology at KRMC

Kalispell, Montana, 59901, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Community Medical Center

Missoula, Montana, 59801, United States

Location

Guardian Oncology and Center for Wellness

Missoula, Montana, 59804, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45406, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Cancer Care Center

Dayton, Ohio, 45415, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

Blanchard Valley Medical Associates

Findlay, Ohio, 45840, United States

Location

Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

Location

Community Oncology Group at Cleveland Clinic Cancer Center

Independence, Ohio, 44131, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373-1300, United States

Location

Clinton Memorial Hospital

Wilmington, Ohio, 45177, United States

Location

Cleveland Clinic - Wooster

Wooster, Ohio, 44691, United States

Location

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baylor University Medical Center - Houston