Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lymphoma

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Lymphosarcoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Rituximab

Sapacitabine

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

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.

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.

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.

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

William G. Wierda, MD, PHD, BS

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.

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.

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

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

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.

Time from date of treatment start until date of death due to any cause or last Follow-up.

Cyclacel Pharmaceuticals, Inc.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

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.

Cyclophosphamide: 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.

Rituximab: 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.

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

Cyclophosphamide, Rituximab + Sapacitabine

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

William G Wierda, MD/Professor

Overall Response Rate (ORR)

Overall Survival

Overall Study

Syndrome

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Precancerous Conditions

sapacitabine administered every 12 hours for 7 days followed by 14 days of rest or every 12 hours for 3 consecutive days per week for 2 weeks followed by 7 days of rest in patients with advanced leukemias or myelodysplastic syndromes The starting dose is (A) 75 mg twice daily x 7 days followed by 14 days of rest; Evaluated doses: 75mg, 100mg, 125mg, 175mg, 225mg, 275mg, 325mg and 375mg

The starting dose is 375 mg twice daily x 3 consecutive days per week for 2 weeks followed by 7days of rest.

Evaluated doses: 375mg, 425mg and 475mg

sapacitabine

Judy H Chiao, MD

The goal of this safety/pharmacology study is to determine MTD of sapacitabine when administered in patients with advanced leukemias or myelodysplastic syndromes.

The goal of this study is to find the highest tolerable dose of sapacitabine that can be given to patients with advanced leukemias or myelodysplastic syndromes.

The starting dose is (A) 75 mg twice daily x 7 days followed by 14 days of rest or, (B) 375 mg twice daily x 3 consecutive days per week for 2 weeks followed by 7days of rest.

Evaluated doses in schedule A: 75mg, 100mg, 125mg, 175mg, 225mg, 275mg, 325mg and 375mg Evaluated doses in schedule B: 375mg, 425mg and 475mg

Safety and Pharmacology Study of Sapacitabine to Treat Advanced Leukemias or Myelodysplastic Syndromes

A Phase I Pharmacologic Study of Oral Sapacitabine in Patients With Advanced Leukemias or Myelodysplastic Syndromes

dose limiting toxicities; during first cycle, each cycle is three weeks

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Venetoclax

Decitabine

Antimetabolites

Enzyme Inhibitors

decitabine will be administered in alternating cycles with sapacitabine

sapacitabine will be administered concomitantly with venetoclax

sapacitabine and decitabine (Part 1 - completed)

sapacitabine and venetoclax (Part 2 - recruiting)

Debra Bull - Linderman, RN

Tapan M Kadia, MD

Hagop M Kantarjian, MD

This is a combination study to evaluate sapacitabine administered in alternating cycles with decitabine in previously untreated Acute Myeloid Leukemia (AML) or concomitantly with venetoclax in previously treated AML or MDS

This is an open-label, single arm, study of sapacitabine administered in alternating cycles with decitabine in elderly patients with previously untreated AML (Part 1) or concomitantly with venetoclax in adult patients with relapsed or refractory AML or MDS (Part 2). Treatment will be administered on an outpatient basis. One treatment cycle is 4 weeks.

Study of Sapacitabine in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)

A Phase I/II Combination Study of Sapacitabine in Acute Myeloid Leukemia or Myelodysplastic Syndromes

Arm A sapacitabine administered in alternating cycles with decitabine

Hagop M Kantarjian, M.D.

This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.

This is a multicenter, randomized, Phase 3 study ("SEAMLESS") comparing two drug regimens (arms) as the front-line treatment of elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy. In Arm A, sapacitabine is administered in alternating cycles with decitabine, and in Arm C decitabine is administered alone. The primary efficacy endpoint is overall survival. The study is designed to demonstrate an improvement in overall survival of Arm A versus Arm C.

A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

The distribution of overall survival was estimated by the method of Kaplan and Meier. A log-rank analysis stratified by randomization stratification factors was used to compare overall survival between Arm A (decitabine/sapacitabine) versus Arm C (decitabine). Cox proportional hazards models were used to identify predictive factors for overall survival.

Normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, and bone marrow to \<=5 % blasts; independent of transfusions\*; and no extramedullary leukemia.

\* independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Normalization of bone marrow to \<=5% blasts; peripheral neutrophils \>=1000 /microliter, platelet \<=100,000 /microliter within 2 weeks of bone marrow biopsy/aspirate; independent of transfusions\*; and no extramedullary leukemia.

\*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, \>=50% decrease in bone marrow blasts over pre-treatment but still \>5%; independent of transfusions\*

\*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

HI with duration (HI)

1. Erythroid response (HI-E) for patients with pre-treatment hemoglobin \< 11 g/dL; Major response: \>2 g/dL increase in hemoglobin; for RBC, transfusion independence\* Minor response: 1 to 2 g/dL increase in hemoglobin; for RBC, a 50% decrease in transfusion requirements
2. Platelet response (HI-P) for pre-treatment platelet count \<100,000/mm3; Major response: an absolute increase of platelet count by \>=30,000/mm3; stabilization of platelet counts and platelet transfusion independence\* Minor response: \>=50% increase in platelet count with a net increase \> 10,000/mm3 but \<30,000/mm3
3. Neutrophil response (HI-N) for absolute neutrophil count (ANC) \< 1,500/mm3 before therapy; Major response: \>=100% increase, or an absolute increase of \>500/mm3, whichever is greater Minor response: \>=100% increase, but absolute increase \< 500/mm3

   * independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Failure to achieve at least hematologic improvement (HI), but no evidence of clinically significant progression for \> 16 weeks.

Number of units of packed red blood cells (PRBC) and/or platelet transfusions administered per 8-week period prior to the first dose of study drug and through the date of treatment discontinuation.

One-year survival is the percentage of patients who are alive at 1-year measured from the date of randomization.

Durations of normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, and bone marrow to \<=5 % blasts; independent of transfusions\*; and no extramedullary leukemia.

\* independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Duration of normalization of bone marrow to \<=5% blasts; peripheral neutrophils \>=1000 /microliter, platelet \<=100,000 /microliter within 2 weeks of bone marrow biopsy/aspirate; independent of transfusions\*; and no extramedullary leukemia.

\*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Duration of normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, \>=50% decrease in bone marrow blasts over pre-treatment but still \>5%; independent of transfusions\*

\*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Duration of HI

1. Erythroid response (HI-E) for patients with pre-treatment hemoglobin \< 11 g/dL; Major response: \>2 g/dL increase in hemoglobin; for RBC, transfusion independence\* Minor response: 1 to 2 g/dL increase in hemoglobin; for RBC, a 50% decrease in transfusion requirements
2. Platelet response (HI-P) for pre-treatment platelet count \<100,000/mm3; Major response: an absolute increase of platelet count by \>=30,000/mm3; stabilization of platelet counts and platelet transfusion independence\* Minor response: \>=50% increase in platelet count with a net increase \> 10,000/mm3 but \<30,000/mm3
3. Neutrophil response (HI-N) for absolute neutrophil count (ANC) \< 1,500/mm3 before therapy; Major response: \>=100% increase, or an absolute increase of \>500/mm3, whichever is greater Minor response: \>=100% increase, but absolute increase \< 500/mm3

   * independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.

Sapacitabine administered in alternating cycles with decitabine

Sapacitabine: Oral sapacitabine capsules

Decitabine: Decitabine intravenous

(n=21, not included in randomization)

Lead In Phase

Arm A sapacitabine administered in alternating cycles with decitabine

Sapacitabine: Oral sapacitabine capsules

Decitabine: Decitabine intravenous

Sapacitabine-decitabine Alternating

Arm C Decitabine

Decitabine: Decitabine intravenous

Total

Age, Continuous

Caucasian

Black

Asian or Pacific Islander

Hispanic

American Indian or Alaska Native

Other

Unknown

Race/Ethnicity, Customized

Elderly patients with newly diagnosed acute myeloid leukemia (AML) for whom the treatment of choice was low-intensity therapy by investigator assessment, or who had refused intensive induction therapy recommended by the investigator.

Point to note: The Lead-in AML patients in the sapacitabine-decitabine alternate dosing arm (n=21) were not considered for efficacy assessment.

Mark H. Kirschbaum MD

The phase III part planned to randomize 485 patients, about 243 per arm (actual 241 patients per arm), over an estimated period of 24 months. Final analysis would occur at approximately 424 deaths, which was expected to be observed about 43 months after the accrual of the first patient. A stratified log rank analysis would have 90% power to detect a 27.5% reduction in the risk of death, i.e., a hazard ratio of 0.725, between Arm A and Arm C.

Subgroup analyses (pre-specified): Presence of antecedent MDS or MPD (covariate)

Treatment covariate: alternating sapacitabine/decitabine treatment Levels: No (i.e., de novo) vs Presence of antecedent MDS or MPD

Subgroup analyses (pre-specified): Baseline peripheral WBC count ≥ 10 x 109/L (covariate)

Treatment covariate: alternating sapacitabine/decitabine treatment Levels: Baseline WBC count ≥ 10 x 109/L vs WBC count ≤ 10 x 109/L

Subgroup analyses (pre-specified): Baseline bone marrow blast percentage ≥ 50% (covariate)

Treatment covariate: alternating sapacitabine/decitabine treatment Levels: Baseline bone marrow blast percentage ≥ 50% vs Blast percentage ≤ 50%

Subgroup analyses (pre-specified): Unfavorable cytogenetics risk by SWOG (covariate)

Treatment covariate: alternating sapacitabine/decitabine treatment Levels: Unfavorable cytogenetics vs other

Subgroup analyses (post-hoc): Region (covariate)

Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: EU vs US

Subgroup analyses (post-hoc): Age (covariate)

Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: ≥ 75 years old vs ≤ 75 years old

Subgroup analyses (post-hoc): Gender (covariate)

Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: Male vs Female

Subgroup analyses (post-hoc): ECOG status (covariate)

Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: Status 2 vs \< 2

Subgroup analyses (post-hoc): HCT-CI score (covariate)

Treatment covariate: alternating sapacitabine/decitabine treatment Levels: HCT-CI score 0-2 vs HCT-CI score \>2

Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function

Complete Remission (CR)

Complete Remission With Incomplete Platelet Count Recovery (CRp)

Partial Remission (PR)

Hematological Improvement

Stable Disease (SD)

Blood Products Transfused

Hospitalized Days

Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function.

1-year Survival

Duration of Complete Remission (dCR)

Duration of Complete Remission With Incomplete Platelet Count Recovery (dCRp)

Duration of Partial Remission (dPR)

Duration of Hematological Improvement (dHI)

Duration of Stable Disease (dSD)

Decitabine alternating with sapacitabine (n=21). Patients followed for safety. Lead in group is not included in ITT analysis of randomized portion of the trial.

Arm A patients received sapacitabine capsules in alternating cycles with decitabine i.e., Cycle 1=decitabine, Cycle 2=sapacitabine, Cycle 3=decitabine, Cycle 4=sapacitabine, etc. Arm A is preceded by a Lead-in phase in selected patients.

Sapacitabine: Oral capsules; 300 mg twice daily (b.i.d.) orally x 3 consecutive days/week x 2 weeks every 8 weeks Decitabine: Decitabine intravenous; 20 mg/m2 infused over 1 hour intravenously/day x 5 consecutive days every 8 weeks Patients continued treatment until one of the following occurred: clinically significant progressive disease; lack of efficacy; unacceptable toxicity; patient withdrawal of consent; investigator's assessment; intercurrent illness or changes in patient's condition that rendered the patient ineligible or continuing treatment unsafe, or regular follow-up impossible; a pattern of non-compliance with study medication or protocol-required evaluations and follow-up; or termination of the clinical trial by the sponsor.

Arm C patients received decitabine infusion.

Decitabine: Intravenous; 20 mg/m2 infused over 1 hour intravenously/day x 5 consecutive days every 8 weeks

Patients continued treatment until one of the following occurred: clinically significant progressive disease; lack of efficacy; unacceptable toxicity; patient withdrawal of consent; investigator's assessment that it was in the best interest of the patient to withdraw; intercurrent illness or changes in patient's condition that rendered the patient ineligible or continuing treatment unsafe, or regular follow-up impossible; a pattern of non-compliance with study medication or protocol-required evaluations and follow-up; or termination of the clinical trial by the sponsor.

Randomized Phase III

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, T-Cell, Cutaneous

Lymphoma, Non-Hodgkin

Peripheral T-cell Lymphoma

Cutaneous T-cell Lymphoma

High-dose (Arm A): 200 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest

Low-dose (Arm B): 100 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest

Judy H Chiao, M.D.

This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL).

This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL) who have had progressive, recurrent, or persistent disease on or following 2 systemic therapies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sapacitabine, Cyclophosphamide, Rituximab for Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma (CLL/SLL) With Deletion (11q22-23)	NCT01253460	Leukemia	Cyclophosphamid... Rituximab Sapacitabine	18 Years -	M.D. Anderson Cancer Center
Safety and Pharmacology Study of Sapacitabine to Treat Advanced Leukemias or Myelodysplastic Syndromes	NCT00380653	Leukemias Myelodysplastic...	sapacitabine	18 Years -	Cyclacel Pharmaceuticals, Inc.
Study of Sapacitabine in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)	NCT01211457	Acute Myeloid L... Myelodysplastic...	sapacitabine an... sapacitabine an...	18 Years -	Cyclacel Pharmaceuticals, Inc.
A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia	NCT01303796	Acute Myeloid L...	Sapacitabine Decitabine	70 Years -	Cyclacel Pharmaceuticals, Inc.
A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma	NCT00476554	Cutaneous T-cel...	Sapacitabine	18 Years -	Cyclacel Pharmaceuticals, Inc.

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