Decitabine Versus Azacitidine in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk
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ClinicalTrials.gov Identifier: NCT01720225 |
Recruitment Status :
Completed
First Posted : November 2, 2012
Results First Posted : December 24, 2020
Last Update Posted : December 24, 2020
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The goal of this clinical research study is to compare how two different drugs, decitabine and azacitidine, when given on a shorter than standard dosing schedule can help to control MDS. The safety of the drugs will also be studied.
Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die.
Azacitidine is designed to block certain proteins in cancer cells whose job is to stop the function of the tumor-fighting proteins. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better. This could cause the cancer cells to die.
Condition or disease | Intervention/treatment | Phase |
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Leukemia | Drug: Decitabine Drug: Azacitidine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 113 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Randomized Study of Lower Doses of Decitabine (DAC; 20 mg/m2 IV Daily for 3 Days Every Month) Versus Azacitidine (AZA; 75 mg/m2 SC/IV Daily for 3 Days Every Month) in Myelodysplastic Syndrome (MDS) Patients With Low and Intermediate-1 Risk Disease |
Actual Study Start Date : | November 6, 2012 |
Actual Primary Completion Date : | January 8, 2020 |
Actual Study Completion Date : | January 8, 2020 |
Arm | Intervention/treatment |
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Experimental: Decitabine
Patients randomized to receive Decitabine 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.
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Drug: Decitabine
20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.
Other Names:
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Experimental: Azacitidine
Patients randomized to receive Azacitidine 75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days.
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Drug: Azacitidine
75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days.
Other Names:
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- Participants With a Response [ Time Frame: 56 days ]Overall Response = complete remission (CR) + partial remission (PR) + marrow CR (mCR) + hematologic improvement (HI). CR is normalization of peripheral blood and bone marrow with <5% bone marrow blasts, a peripheral blood granulocyte count > (1.0 x 10^9/L, and platelet count > 100 x 10^9/L). PR is same as CR except for the presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment. Marrow CR is blasts </= 5% and decreased by >/=50% from baseline. HI is platelets increase by 50% and to above 30 x 10^9/L untransfused (if lower than that pre-therapy; or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by > 50%; or monocytosis reduction by > 50% if pretreatment > 5 X1 0^9/L.
- Number of Participants Who Became Transfusion Independent [ Time Frame: 8 weeks ]Participants who were transfusion dependent at baseline prior to starting therapy on the Decitabine or Azacitidine arm will be analyzed for transfusion independence. Transfusion independence defined as being transfusion-free for ≥8 consecutive weeks between the first dose and study treatment discontinuation.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Sign an Institutional Review Board (IRB)-approved informed consent document.
- Age >/= than18 years
- de novo or secondary International Prostate Symptom Score (IPSS) low- or intermediate-1 - risk MDS, including CMML
- Eastern Cooperative Oncology Group (ECOG) performance status of </= 3 at study entry.
- Organ function as defined: Serum creatinine </= 3 x Upper Limit of Normal (ULN), Total bilirubin </= 2 x ULN, Alanine transaminase (ALT) (SGPT) </= 2 x ULN
- Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and will also need to use contraceptives. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
Exclusion Criteria:
- Breast feeding females
- Prior therapy with decitabine or azacitidine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720225
United States, Texas | |
University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Elias Jabbour, MD | M.D. Anderson Cancer Center |
Documents provided by M.D. Anderson Cancer Center:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT01720225 |
Other Study ID Numbers: |
2012-0507 NCI-2012-02215 ( Registry Identifier: NCI CTRP ) |
First Posted: | November 2, 2012 Key Record Dates |
Results First Posted: | December 24, 2020 |
Last Update Posted: | December 24, 2020 |
Last Verified: | December 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Leukemia Myelodysplastic syndromes MDS Low and Intermediate-1 Risk Disease Decitabine DAC Dacogen Azacitidine |
AZA 5-azacytidine 5-aza Vidaza 5-AZC AZA-CR Ladakamycin NSC-102816 |
Preleukemia Myelodysplastic Syndromes Neoplasms Hematologic Diseases Bone Marrow Diseases Precancerous Conditions Azacitidine |
Decitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors |