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Phase I/II Study of Clofarabine Plus Cyclophosphamide for Relapsed and Refractory Acute Lymphoblastic Leukemia (ALL)

Phase 1/Phase 2
21 Years
Not Enrolling
Burkitt's Lymphoma, Lymphoblastic Lymphoma, Acute Lymphoblastic Leukemia

Thank you

Trial Information

Phase I/II Study of Clofarabine Plus Cyclophosphamide for Relapsed and Refractory Acute Lymphoblastic Leukemia (ALL)

Clofarabine is a drug that is designed to interfere and disrupt important metabolic pathways
of cancer cells by interfering with their multiplication and slowing or stopping their
growth. Cyclophosphamide is also designed to destroy cancer cells by interfering with their
multiplication and slowing or stopping their growth and spread throughout the body.
Cyclophosphamide is commonly used in the treatment of ALL.

If you are found to be eligible to take part in this study, you will receive clofarabine by
vein over about 60 minutes, once a day for 3 to 5 days. Cyclophosphamide will be given by
vein over about 3 hours, twice a day for 3 to 5 days. These 3-5 days are considered 1 cycle
of therapy.

As the safety of this combination has not been established yet, at least the first 2
participants on this study will receive clofarabine for 3 days and cyclophosphamide at a
lower dose than usually given for 3 days (6 doses). Should there be no serious side effects
that can be related to the study drugs, the next group of 2 participants will receive
clofarabine over 3 days and a slightly higher dose of cyclophosphamide for 3 days (6 doses).
Should there still be no serious side effects at that level, 2 further levels will be tested
where both clofarabine and cyclophosphamide are then given over 4 days and eventually 5
days. Should serious and study drug-related side effects occur at any point during this
increase of doses, a certain dose level along this increase will be defined as the
appropriate dose for all future participants to receive. It is estimated that about 30
participants will receive therapy during the dose escalations portion of this study (Phase
I). It is estimated that about 25 more participants will receive therapy at the dose
levels that are considered best (Phase II).

During treatment, you will have a physical exam at least once a week. You may also be asked
about the level of your daily activities, how you are feeling, and which medications you are
taking currently. Routine blood samples (about 1 tablespoon each) will be drawn at least 1-3
times weekly and more frequently if considered necessary. A bone marrow aspirate and/or
biopsy will be repeated starting at about Day 14 and will be repeated every 1 to 2 weeks
until the study doctors can decide for sure whether you have responded or not. In some
cases, a repeat bone marrow test may not be necessary, but this decision will be made by
your treating doctor.

If you respond well after your first round of therapy, you may receive up to 6 additional
courses of therapy. Each course will be repeated about every 3 to 7 weeks at a slightly
lower dose of both drugs than was used during the first round of therapy. Later doses can
also be changed depending on what type of side effects you may experienced with earlier
rounds of therapy.

At the end of the study, a heart scan (either an Echo or MUGA scan) will be repeated. About
1 tablespoon of blood will be taken for routine blood tests. A focused physical exam may
also be repeated.

This is an investigational study. All drugs in this study are FDA approved and commercially
available. Their use together in this study is investigational. . About 55 patients will
take part in this study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Previously treated ALL (including Burkitt's lymphoma and lymphoblastic lymphoma) in
relapse or primary refractory. For patients in first relapse, the first remission
duration may not exceed 12 months.

2. Age >/= 21 years.

3. Zubrod performance status
4. Adequate liver function (bilirubin transaminase (SGPT or SGOT) function (glomerular filtration rate [GFR] >/= 60 mL/min). Even if organ function
abnormalities are considered due to tumor, the upper limit for bilirubin is mg/dL and creatinine
5. Male and female patients who are fertile agree to use an effective barrier method of
birth control (e.g., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy.
Female patients need a negative serum or urine pregnancy test within 14 days of study
enrollment (applies only if patient is of childbearing potential. Non-childbearing is
defined as >/= 1 year postmenopausal or surgically sterilized).

Exclusion Criteria:

1. Patients with active heart disease (New York Heart Association (NYHA) class >/= 3 as
assessed by history and physical examination).

2. Patients with a cardiac ejection fraction (as measured by either Multi Gated
Acquisition Scan (MUGA) or echocardiogram) < 45% are excluded.

3. Patients who receive other chemotherapy. Patients must have been off previous therapy
for >/= 2 weeks and must have recovered from acute toxicity of all previous therapy
prior to enrollment. (Concurrent therapy for central nervous system (CNS) prophylaxis
or treatment for CNS relapse is permitted). Treatment may start earlier if
necessitated by the patient's medical condition following discussion with the
Principal Investigator.

4. Pregnant and breast-feeding patients are excluded

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose for Cyclophosphamide (MTD)

Outcome Description:

MTD is dose at which there are no dose limiting toxicity (DLT) defined as any =/> grade 3 drug-related non-hematologic toxicity that occurs within the first 14 days after start of treatment. Evaluation using continual reassessment method; 3-5 Day Cycle

Outcome Time Frame:

First 14 days of each cycle

Safety Issue:


Principal Investigator

Stefan Faderl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

April 2012

Related Keywords:

  • Burkitt's Lymphoma
  • Lymphoblastic Lymphoma
  • Acute Lymphoblastic Leukemia
  • Burkitt's Lymphoma
  • Lymphoblastic Lymphoma
  • Acute Lymphoblastic Leukemia
  • Clofarabine
  • Clofarex
  • Clolar
  • Cyclophosphamide
  • Neosar
  • Cytoxan
  • Burkitt Lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



UT MD Anderson Cancer Center Houston, Texas  77030