LeukemiaPhase 2NCT01253460
Sapacitabine, Cyclophosphamide, Rituximab for Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma (CLL/SLL) With Deletion (11q22-23)
A Phase 2 study testing Cyclophosphamide, Rituximab and Sapacitabine in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Cyclophosphamide, Rituximab and Sapacitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2011to 13 Feb 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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
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.
Read the detailed description
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.
- Conditions
- Leukemia
- Being tested
- Cyclophosphamide, Rituximab, Sapacitabine
- Keywords
- Chronic Lymphocytic Leukemia, CLL, Small Lymphocytic Lymphoma, SLL, Cyclophosphamide, Rituximab, Sapacitabine, Cytoxan, Neosar, Rituxan
- Medical subject headings
- Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called Cytoxan, Neosar
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.
RituximabDrug
Also called Rituxan
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.
SapacitabineDrug
350 mg flat dose by mouth in the morning of days 1,2, and 3 of each 28 day course.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Cyclophosphamide; Drug: Rituximab; Drug: Sapacitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 84 days
Secondary outcomes (1)
Overall Survival
Time from date of treatment start until date of death due to any cause or last Follow-up.
Measured: Up to 8.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study start22 Aug 2011
- Primary completion28 Mar 2018
- Study completion13 Feb 2019
Why it stopped: Accrual not met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cyclacel Pharmaceuticals, Inc., National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- William G. Wierda, MD, PHD, BS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253460
- Sponsor's protocol ID
- 2010-0516
- Other IDs
- NCI-2011-00119, 5P01CA081534
- Status last verified
- Aug 2019
- First submitted
- 1 Dec 2010
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01253460
- Acronym / sponsor ID
- 2010-0516
- Conditions
- Leukemia
- Keywords
- Chronic Lymphocytic Leukemia, CLL, Small Lymphocytic Lymphoma, SLL, Cyclophosphamide, Rituximab, Sapacitabine, Cytoxan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual not met
- Enrolment
- 18 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Cyclacel Pharmaceuticals, Inc., National Cancer Institute (NCI)
- Study start
- 22 Aug 2011 (actual)
- Primary completion
- 28 Mar 2018 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyclophosphamide, Rituximab + Sapacitabine | Experimental | Drug: Cyclophosphamide, Drug: Rituximab, Drug: SapacitabineAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideAlso: Cytoxan, Neosar250 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. | Drug | Cyclophosphamide, Rituximab + Sapacitabine |
| RituximabAlso: Rituxan375 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. | Drug | Cyclophosphamide, Rituximab + Sapacitabine |
| Sapacitabine350 mg flat dose by mouth in the morning of days 1,2, and 3 of each 28 day course. | Drug | Cyclophosphamide, Rituximab + Sapacitabine |
Primary outcome
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). 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.
1 secondary outcome
Overall Survival
Time frame: Up to 8.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William G. Wierda, MD, PHD, BS principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide, Rituximab and Sapacitabine in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.