Clinical trial · Interventional

Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

A Phase II Study Incorporating Sorafenib (NSC 724772) Into the Therapy of Patients >/= 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia

NCT01253070CI-TRIAL-00060113completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This phase II trial studies how well sorafenib tosylate and chemotherapy work in treating older patients with acute myeloid leukemia (AML). Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as daunorubicin hydrochloride and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving sorafenib tosylate and combination chemotherapy may be an effective treatment for AML.

Conditions

Conditions (6)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Acute Myeloid Leukemia With FLT3/ITD Mutation	Acute Myeloid Leukemia with FLT3/ITD Mutation	ONTOLOGY_EXACT	0.98
Acute Myeloid Leukemia With Inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11	Acute Myeloid Leukemia with inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11	ONTOLOGY_EXACT	0.98
Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1	Acute Myeloid Leukemia with t(8;21)(q22;q22.1); RUNX1-RUNX1T1	ONTOLOGY_EXACT	0.98
Acute Promyelocytic Leukemia With PML-RARA	Acute Promyelocytic Leukemia with t(15;17)(q24.1;q21.2); PML-RARA	CURATED_BROADER	0.80
FLT3 Gene Mutation	—	UNRESOLVED	—
Therapy-Related Acute Myeloid Leukemia	Acute Myeloid Leukemia Post Cytotoxic Therapy

Interventions

Interventions (8)

Intervention	Type	Mapped drug	Match
Biopsy	Procedure	—	UNRESOLVED
Bone Marrow Aspiration	Procedure	—	UNRESOLVED
Cytarabine	Drug	Cytarabine	ALIAS
Daunorubicin Hydrochloride	Drug	Daunorubicin	ALIAS
Laboratory Biomarker Analysis	Other	—	UNRESOLVED
Quality-of-Life Assessment	Other	—	UNRESOLVED
Questionnaire Administration	Other	—	UNRESOLVED
Sorafenib Tosylate	Drug	Sorafenib Tosylate	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Treatment (daunorubicin, cytarabine, sorafenib tosylate)
description
INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m\^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m\^2/day by continuous IV on days 1-7, and sorafenib tosylate orally every 12 hours on days 1-7. CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m\^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28. MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
interventionNames
1. Procedure: Biopsy
2. Procedure: Bone Marrow Aspiration
3. Drug: Cytarabine
4. Drug: Daunorubicin Hydrochloride
5. Other: Laboratory Biomarker Analysis
6. Other: Quality-of-Life Assessment
7. Other: Questionnaire Administration
8. Drug: Sorafenib Tosylate

Primary outcomes (1)

measure
Overall Survival (OS) Rate
timeFrame
1 year
description

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 60 Years

Show eligibility criteria text

Inclusion Criteria:

* Unequivocal histologic diagnosis of AML according to World Health Organization (WHO) criteria, EXCLUDING:

  * Acute promyelocytic leukemia t(15;17)(q22;q12); promyelocytic leukemia (PML)-retinoic acid receptor, alpha (RARA)
  * Acute myeloid leukemia with t(8;21)(q22;q22); runt-related transcription factor 1 (RUNX1-RUNXT1) as determined by the Ohio State University (OSU) Molecular Reference Laboratory, per CALGB 20202
  * Acute myeloid leukemia with inv(16)(p13.1;q22) or t(16;16(p13.1;q22); core-binding factor, beta subunit (CBFB)-myosin, heavy chain 11, smooth muscle (MYH11) as determined by the OSU Molecular Reference Laboratory, per CALGB 20202
* AML patients with an antecedent hematologic disorder are eligible for treatment on this trial provided that they have not received chemotherapy, including lenalidomide, azacitidine or decitabine for their hematologic disorder; patients with therapy-related AML are eligible if there had been no further exposure to chemotherapy or radiation therapy for \> 3 years and their primary malignancy is in remission
* FLT3 mutation (ITD or point mutation) determined by the OSU Molecular Reference Laboratory, per CALGB 20202
* No prior chemotherapy for AML with the following exceptions:

  * Emergency leukapheresis
  * Emergency treatment for hyperleukocytosis with hydroxyurea
  * Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one dose only)
  * Growth factor/cytokine support
  * All-trans retinoic acid (ATRA)

References

Publications (5)

DERIVEDSeffernick AE, Mrozek K, Nicolet D, Stone RM, Eisfeld AK, Byrd JC, Archer KJ. High-dimensional genomic feature selection with the ordered stereotype logit model. Brief Bioinform. 2022 Nov 19;23(6):bbac414. doi: 10.1093/bib/bbac414. PMID 36184192
DERIVEDMims AS, Kohlschmidt J, Borate U, Blachly JS, Orwick S, Eisfeld AK, Papaioannou D, Nicolet D, Mromicronzek K, Stein E, Bhatnagar B, Stone RM, Kolitz JE, Wang ES, Powell BL, Burd A, Levine RL, Druker BJ, Bloomfield CD, Byrd JC. A precision medicine classification for treatment of acute myeloid leukemia in older patients. J Hematol Oncol. 2021 Jun 23;14(1):96. doi: 10.1186/s13045-021-01110-5. PMID 34162404
DERIVEDKlepin HD, Ritchie E, Major-Elechi B, Le-Rademacher J, Seisler D, Storrick L, Sanford BL, Marcucci G, Zhao W, Geyer SA, Ballman KV, Powell BL, Baer MR, Stock W, Cohen HJ, Stone RM, Larson RA, Uy GL. Geriatric assessment among older adults receiving intensive therapy for acute myeloid leukemia: Report of CALGB 361006 (Alliance). J Geriatr Oncol. 2020 Jan;11(1):107-113. doi: 10.1016/j.jgo.2019.10.002. Epub 2019 Oct 24. PMID 31668825
DERIVEDYin J, LaPlant B, Uy GL, Marcucci G, Blum W, Larson RA, Stone RM, Mandrekar SJ. Evaluation of event-free survival as a robust end point in untreated acute myeloid leukemia (Alliance A151614). Blood Adv. 2019 Jun 11;3(11):1714-1721. doi: 10.1182/bloodadvances.2018026112. PMID 31171508
DERIVEDUy GL, Mandrekar SJ, Laumann K, Marcucci G, Zhao W, Levis MJ, Klepin HD, Baer MR, Powell BL, Westervelt P, DeAngelo DJ, Stock W, Sanford B, Blum WG, Bloomfield CD, Stone RM, Larson RA. A phase 2 study incorporating sorafenib into the chemotherapy for older adults with FLT3-mutated acute myeloid leukemia: CALGB 11001. Blood Adv. 2017 Jan 24;1(5):331-340. doi: 10.1182/bloodadvances.2016003053. PMID 29034366

Registry

Dates and enrollment

Start: Apr 1, 2011
Primary completion: Oct 31, 2014
Completion: Apr 15, 2021
First posted: Dec 3, 2010
Last update posted: Aug 4, 2022
Results first posted: Feb 11, 2016
Enrollment: 54 (actual)
Lead sponsor: National Cancer Institute (NCI) NIH

Data updated 22 days agoSource updated Aug 4, 2022source: clinicaltrials

Locations

Locations by country (43)

Country	Sites	Recruiting
United States	43	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.