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Anti-metabolites

Cladribine + LDAC + Decitabine for Acute Myeloid Leukemia and Myelodysplastic Syndrome

Q: Are new participants being accepted into this clinical trial?

This is an ongoing trial, as indicated by the clinicaltrials.gov website. The posting went up on 2/7/2012 and was edited as recently as 8/23/2022.

Q: Are there any other precedents for Cytarabine in medical research?

Currently, 354 clinical trials are running that involve Cytarabine. 78 of these active studies are in their third and final phase. Most of the research being conducted for Cytarabine is taking place in Providence, <a href="https://www.withpower.com/clinical-trials/rhode-island">Rhode island</a>; however, 10755 locations worldwide are running similar studies.

Q: What type of cancer does Cytarabine target?

Cytarabine is an effective treatment for patients with intermediate-2 ipss risk category, refractory anemias, and blast phase chronic myelocytic <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>.

Q: Has Cytarabine received approval from the Federal Drug Administration?

While no Phase 2 trials have been run for cytarabine, there is enough data to support its safety.

Q: How many test subjects are being given the opportunity to participate in this research?

Yes, the information on clinicaltrials.gov suggests that this clinical trial is currently recruiting participants. The clinical trial was originally posted on 2/7/2012 and was last updated on 8/23/2022. The clinical trial is recruiting for 160 patients across 1 sites.

Phase 2

Recruiting

Led By Tapan Kadia, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with previously untreated AML or high risk MDS (>/= 10 % blasts or IPSS >/= intermediate-2).

Adequate organ function: liver function (bilirubin < 2mg/dL, AST and/or ALT <3 x ULN), kidney function (creatinine < 1.5 x ULN), ECOG performance status of ≤ 2.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 21

Awards & highlights

Study Summary

This trial is studying a combination of drugs as a potential treatment for AML or MDS.

Who is the study for?

This trial is for adults aged 18 or older with untreated AML or high-risk MDS, who are not suitable for standard therapy. Participants must understand the study and consent to it, have adequate organ function, and agree to use contraception. Pregnant women, those with uncontrolled illnesses or hypersensitivity to the drugs used in this trial cannot participate.Check my eligibility

What is being tested?

The study tests a combination of Cladribine, Cytarabine (LDAC), and Decitabine on patients with AML or MDS. It aims to see if these drugs can control the disease by interfering with cancer cells' DNA processing and repair mechanisms. Up to 160 participants will be enrolled at MD Anderson.See study design

What are the potential side effects?

Potential side effects may include damage to DNA leading to cell death which could cause symptoms like fatigue, nausea, infections due to low blood counts, liver dysfunction indicated by elevated bilirubin levels, and other organ-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have AML or high-risk MDS without prior treatment.

Select...

My liver and kidney functions are within normal limits and I can care for myself.

Select...

I have AML and haven't been treated or eligible for other AML clinical trials.

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My creatinine or bilirubin levels are high, or I am mostly bedridden.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 21

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 21

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 21 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease-Free Survival (DFS)

Side effects data

From undefined Phase 3 trial • 1734 Patients • NCT00025259

80%

Neutrophil count decreased

42%

Anemia

31%

Platelet count decreased

26%

Febrile neutropenia

18%

White blood cell decreased

16%

Infections and infestations - Other, specify

Blood and lymphatic system disorders - Other, specify

Lymphocyte count decreased

Catheter related infection

Dehydration

Abdominal pain

Mucositis oral

Vomiting

Anaphylaxis

Hypokalemia

Hypotension

Hypoxia

Depression

Hyponatremia

Immune system disorders - Other, specify

Myalgia

Dizziness

Constipation

Esophagitis

Ileus

Pain

Carbon monoxide diffusing capacity decreased

Hypoalbuminemia

Neuralgia

Peripheral sensory neuropathy

Dyspnea

Diarrhea

Typhlitis

Hyperglycemia

Headache

Seizure

Syncope

Nausea

Cardiac disorders - Other, specify

Hypophosphatemia

Bone pain

Peripheral motor neuropathy

Thromboembolic event

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Arm III (RER With CR [ABVE-PC])

Arm I (Patients Off-therapy Before Callback-Induction Only)

Arm II (RER With CR [ABVE-PC, IFRT])

Arm IV (RER With Less Than CR [ABVE-PC, IFRT])

Arm VII (SER [ABVE-PC, IFRT])

Arm VI (SER [DECA, ABVE-PC, IFRT])

Arm V (RER With PD)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cladribine + Cytarabine Alt. with DecitabineExperimental Treatment3 Interventions

Induction cycle: Cladribine intravenous (IV) over approximately 1 to 2 hours, daily on days 1-5 combined with Cytarabine subcutaneous (SQ) twice daily on days 1-10. Cytarabine should be administered approximately 3-6 hours following the start of the cladribine infusion. Consolidation cycle: Cladribine IV over 1 to 2 hours, daily on days 1-3 combined with Cytarabine SQ twice daily on days 1-10. Cytarabine should be administered 3-6 hours following the start of the cladribine infusion. Alternating with: Decitabine IV over 1 to 2 hours, daily on days 1-5.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cladribine

2014

Completed Phase 4

~4390

Cytarabine

2016

Completed Phase 3

~3310

Decitabine

2004

Completed Phase 3

~1680

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,977 Previous Clinical Trials

1,789,378 Total Patients Enrolled

453 Trials studying Leukemia

31,410 Patients Enrolled for Leukemia

Tapan Kadia, MDPrincipal InvestigatorM.D. Anderson Cancer Center

5 Previous Clinical Trials

497 Total Patients Enrolled

3 Trials studying Leukemia

486 Patients Enrolled for Leukemia

Media Library

Cladribine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT01515527 — Phase 2

Leukemia Research Study Groups: Cladribine + Cytarabine Alt. with Decitabine

Leukemia Clinical Trial 2023: Cladribine Highlights & Side Effects. Trial Name: NCT01515527 — Phase 2

Cladribine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01515527 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being accepted into this clinical trial?

"This is an ongoing trial, as indicated by the clinicaltrials.gov website. The posting went up on 2/7/2012 and was edited as recently as 8/23/2022."

Answered by AI

Are there any other precedents for Cytarabine in medical research?

"Currently, 354 clinical trials are running that involve Cytarabine. 78 of these active studies are in their third and final phase. Most of the research being conducted for Cytarabine is taking place in Providence, Rhode island; however, 10755 locations worldwide are running similar studies."

Answered by AI

What type of cancer does Cytarabine target?

"Cytarabine is an effective treatment for patients with intermediate-2 ipss risk category, refractory anemias, and blast phase chronic myelocytic leukemia."

Answered by AI

Has Cytarabine received approval from the Federal Drug Administration?

"While no Phase 2 trials have been run for cytarabine, there is enough data to support its safety."

Answered by AI

How many test subjects are being given the opportunity to participate in this research?

"Yes, the information on clinicaltrials.gov suggests that this clinical trial is currently recruiting participants. The clinical trial was originally posted on 2/7/2012 and was last updated on 8/23/2022. The clinical trial is recruiting for 160 patients across 1 sites."

Answered by AI

Recent research and studies

The Lancet HaematologyJournal

Cladribine and Low-dose Cytarabine Alternating with Decitabine as Front-line Therapy for Elderly Patients with Acute Myeloid Leukaemia: A Phase 2 Single-arm Trial

Kadia, Tapan M, Jorge Cortes, Farhad Ravandi, Elias Jabbour, Marina Konopleva, Christopher B Benton, Jan Burger, et al.. 2018. “Cladribine and Low-dose Cytarabine Alternating with Decitabine as Front-line Therapy for Elderly Patients with Acute Myeloid Leukaemia: A Phase 2 Single-arm Trial”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(18)30132-7.

clinicaltrials.govStudy

Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)

2012. "Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01515527.

All > Acute Myeloid Leukemia > Leukemia