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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

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


The Study Drugs:

Sapacitabine and cyclophosphamide are designed to damage the DNA (genetic material) of
cancer cells, which may cause the cancer cells to die.

Rituximab is designed to attach to cancer cells and damage them, which may cause the cancer
cells to die. It is also designed to cause the immune system to attack cancer cells.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive sapacitabine by
mouth 1 time a day on Days 1-3 of each 28-day cycle. Try to take sapacitabine at least 1
hour before or 2 hours after a meal. On Days 1-3 of each cycle, you will also receive
cyclophosphamide by vein over 30 minutes, starting 2 hours after you take sapacitabine.

On Day 3 of Cycle 1 and Day 1 of Cycles 2 and beyond, you will receive rituximab by vein
over 6-8 hours.

If side effects occur, the study doctor may decide to lower your study drug doses. If you
have side effects during a dose, the study staff will check you for any other problems for 2
hours after the dose.

Other Drugs:

On Days 1-14 of Cycle 1, you will take allopurinol by mouth 1 time a day to lower the risk
of kidney damage.

Before each dose of cyclophosphamide, you will receive Zofran (ondansetron) by vein over a
few seconds to lower the risk of nausea.

About 30-60 minutes before each dose of rituximab, you will take Tylenol (acetaminophen) and
Benadryl (diphenhydramine hydrochloride) by mouth to lower the risk of side effects such as
fever and chills.

Study Visits:

On Day 1 of each cycle:

- Blood (about 1-2 tablespoons) will be drawn for routine tests.

- You will also have a physical exam, including measurement of your vital signs, except
Cycle 1.

- You will be asked about any side effects you may have had.

On Days 8 and 22 of Cycle 1, and on Day 15 of every cycle:

- Blood (about 1-2 tablespoons) will be drawn for routine tests.

- You will be asked about any side effects you may have had.

If your disease has had a good response and the doctor thinks it is needed to check the
status of the disease, you will have a bone marrow aspiration and biopsy and a CT scan of
the chest, abdomen and pelvis prior to Cycle 4 and possibly every other cycle after that
(Cycles 6, 8, 10, and so on).

Length of Study:

Once your doctor thinks the disease has had its best response, you may receive 2 more cycles
of study therapy after that. You will no longer be able to receive the study drugs if the
disease gets worse or intolerable side effects occur.

End-of-Treatment Visit:

The following tests and procedures will be performed after your last cycle of study drugs:

- You will have a physical exam, including measurement of your vital signs.

- Blood (about 2 tablespoons) will be drawn for routine tests.

Follow-Up Visits:

At 2 and 6 months and 1 and 2 years after your last dose of study drugs:

- You will be asked about any side effects you may have had and any drugs you may be
taking.

- You will have a physical exam, including measurement of your vital signs.

- Blood (about 1 tablespoon) will be drawn for routine tests.

- If the doctor thinks the disease has completely responded, you will have a CT scan of
the neck, chest, abdomen, and pelvis to confirm the response. You will also have a
bone marrow aspiration and biopsy to confirm the response.

At 3 years after your last dose of study drugs and 1 time a year from then on:

- You will be asked about any side effects you may have had and any drugs you may be
taking.

- You will have a physical exam, including measurement of your vital signs.

- Blood (about 1 tablespoon) will be drawn for routine tests.

- You will have a bone marrow aspiration and biopsy if the doctor decides it is needed to
check the status of the disease.

If the doctor thinks it is needed anytime during follow-up, you will have a CT scan of the
neck, chest, abdomen, and pelvis to check the status of the disease.

Starting at Year 3, the follow-up tests and procedures can be done by your local doctor if
that is more convenient to you. The test results should be sent to MD Anderson.

You should tell your study doctor or staff if you start another cancer treatment during
follow-up. If that occurs, your follow-up in this study will stop.

This is an investigational study. Sapacitabine is not FDA approved or commercially
available. It is currently being used for research purposes only. Cyclophosphamide and
rituximab are FDA approved and commercially available to treat CLL and SLL. The combination
of sapacitabine, cyclophosphamide, and rituximab is investigational.

Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.


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
6. Adequate renal and hepatic function as indicated by all the following: serum
creatinine of normal; AND total bilirubin
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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Response Rate (ORR)

Outcome Description:

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).

Outcome Time Frame:

84 days

Safety Issue:

Yes

Principal Investigator

William G. Wierda, MD, PHD, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2010-0516

NCT ID:

NCT01253460

Start Date:

July 2011

Completion Date:

Related Keywords:

  • Leukemia
  • Chronic Lymphocytic Leukemia
  • CLL
  • Small Lymphocytic Lymphoma
  • SLL
  • Cyclophosphamide
  • Rituximab
  • Sapacitabine
  • Cytoxan
  • Neosar
  • Rituxan
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030