Who is sponsoring NCT01254578?

NCT01254578 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT01254578?

Interventions in NCT01254578: Laboratory Biomarker Analysis, Lenalidomide, Pharmacological Study.

What condition does NCT01254578 study?

NCT01254578 studies Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A, Adult Acute Promyelocytic Leukemia With PML-RARA, Adult Grade III Lymphomatoid Granulomatosis, Adult Nasal Type Extranodal NK/T-Cell Lymphoma, Alkylating Agent-Related Acute Myeloid Leukemia, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-Cell Lymphoma, Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Hepatosplenic T-Cell Lymphoma, Intraocular Lymphoma, Lymphomatous Involvement of Non-Cutaneous Extranodal Site, Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Nodal Marginal Zone Lymphoma, Post-Transplant Lymphoproliferative Disorder, Primary Cutaneous B-Cell Non-Hodgkin Lymphoma, Prolymphocytic Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Immunoblastic Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-Cell Leukemia/Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides and Sezary Syndrome, Recurrent Non-Hodgkin Lymphoma, Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hairy Cell Leukemia, Richter Syndrome, Small Intestinal Lymphoma, Splenic Marginal Zone Lymphoma, T-Cell Large Granular Lymphocyte Leukemia, Testicular Lymphoma, Waldenstrom Macroglobulinemia.

Is NCT01254578 still recruiting?

NCT01254578 is currently completed. Last updated 25 September 2017.

Last reviewed 2017-09-25 · How we verify

NCT01254578

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Lenalidomide After Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancers

Completed Phase 1 Last updated 25 September 2017

What this trial tests

Phase 1 trial testing Laboratory Biomarker Analysis in Adult Acute Myeloid Leukemia in Remission in 17 participants. Completed in 9 November 2012.

Timeline

24 November 2010

Primary endpoint
9 November 2012

9 November 2012

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	17
Start date	24 November 2010
Primary completion	9 November 2012
Estimated completion	9 November 2012
Sites	1 location across United States

Drugs / interventions tested

Laboratory Biomarker Analysis — full drug profile →
Lenalidomide — full drug profile →
Pharmacological Study — full drug profile →

Conditions studied

Adult Acute Myeloid Leukemia in Remission — all drugs for Adult Acute Myeloid Leukemia in Remission →
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 — all drugs for Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 →
Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11 — all drugs for Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11 →
Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1 — all drugs for Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1 →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Adult Acute Myeloid Leukemia in Remission or Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I clinical trial is studying the side effects and the best dose of lenalidomide after donor bone marrow transplant in treating patients with high-risk hematologic cancer. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Novel immunotherapeutic approaches for the treatment of acute leukemia (myeloid and lymphoblastic).
Ishii K, Barrett AJ. · · 2016 · cited 8× · PMID 26834952 · DOI 10.1177/2040620715616544
Phase I Clinical Trials in Acute Myeloid Leukemia: 23-Year Experience From Cancer Therapy Evaluation Program of the National Cancer Institute.
Zeidner JF, Karp JE, Blackford AL, Foster MC, et al · · 2016 · cited 7× · PMID 26553781 · DOI 10.1093/jnci/djv335
Therapeutic Activity of Lenalidomide in Mantle Cell Lymphoma and Indolent Non-Hodgkin's Lymphomas.
Gunnellini M, Falchi L. · · 2012 · cited 6× · PMID 22761620 · DOI 10.1155/2012/523842
Novel Approaches for the Treatment of Patients with Richter's Syndrome.
Iannello A, Deaglio S, Vaisitti T. · · 2022 · cited 5× · PMID 35294723 · DOI 10.1007/s11864-022-00973-1

Verify or expand the search:

Other trials of Laboratory Biomarker Analysis

Trials testing the same drug.

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NCT05564650 — Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome · Phase 1 · active not recruiting
NCT05396859 — Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia · Phase 1 · active not recruiting

Other recruiting trials for Adult Acute Myeloid Leukemia in Remission

Currently open trials in the same condition.

NCT02159495 — Genetically Modified T-cell Immunotherapy in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia and Persi · Phase 1 · active not recruiting
NCT01885689 — Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in · Phase 2 · active not recruiting

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01254578 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 25 September 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01254578.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing