NCT00854581

Prospective Study of the Molecular Characteristics of Sensitive and Resistant Disease in Patients With HTLV-I Associated Adult T Cell Leukemia Treated With Zidovudine (AZT) Plus Interferon Alpha-2b

Terminated Phase 4 Results posted Last updated 19 March 2018

What this trial tests

Phase 4 trial testing PEG-interferon alfa-2b in Lymphoma in 13 participants. Terminated before completion.

Timeline

1 November 2007

Primary endpoint
1 June 2011

1 November 2011

Quick facts

Lead sponsor	University of Miami
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	1 November 2007
Primary completion	1 June 2011
Estimated completion	1 November 2011
Sites	1 location across United States

Drugs / interventions tested

• PEG-interferon alfa-2b — full drug profile →
• Interferon alfa-2b (INTERFERON ALFA-2B) — full drug profile →
• Valproic Acid (valproic acid) — full drug profile →
• Zidovudine (ZIDOVUDINE) — full drug profile →

Conditions studied

• Lymphoma — all drugs for Lymphoma →
• Precancerous/Nonmalignant Condition — all drugs for Precancerous/Nonmalignant Condition →

Sponsor

University of Miami

Who can join

18 and older, any sex, with Lymphoma or Precancerous/Nonmalignant Condition. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Patients Achieving Clinical Response to Protocol Therapy Who Lack IRF-4 and/or c-Rel Expression.
  Time frame: Up to 12 months post-initiation of protocol therapy
  Number of patients achieving clinical response (complete response (CR) + partial response (PR)) who lack interferon regulatory factor 4 (IRF-4) or c-Rel biomarker expression. Treatment response was assessed according to the International Consensus Review's adult T-cell leukemia/lymphoma (ATLL) consensus report by Tsukasaki et al published in the Journal of Clinical Oncology (JCO) in 2009. For ima
• Presence of Minimal Residual Disease at 3 and 6 Months of Maintained Remission and at 1 Year Post Initiation of Therapy
  Time frame: 3, 6 and 12 months.
  Number of participants achieving complete response (CR) with minimal residual disease at 3, 6 and 12 months post-initiation of protocol therapy. Treatment response was assessed according to the International Consensus Review's adult T-cell leukemia/lymphoma (ATLL) consensus report by Tsukasaki et al published in the Journal of Clinical Oncology (JCO) in 2009. For imaging, Cheson criteria was used
• Expressions of c-Rel, IRF-4 and Other Molecular Events in Participants
  Time frame: At time of relapse or disease progression, assessed up to 12 months
  Expressions of c-Rel, IRF-4 or other molecular events (p53, p16 mutations) including expansion of novel clones obtained at time of relapse will be compared to baseline data using paired t-test.
• Number of Participants Exhibiting NF-kB Inhibition Upon Treatment With AZT in Vivo
  Time frame: During 48 hours of first AZT therapy
  Number of patients exhibiting NF-kb inhibition upon treatment with AZT in vivo. Investigation of whether AZT functions as an inhibitor of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) in vivo by analyzing serially collected leukemic samples during the first 48 hours of treatment with AZT only. The investigators will report the number of participants exhibiting NF-kB inhibi
• The Effect of Valproic Acid Therapy on Persistence of Clonal Disease in Patients Who Achieve Clinical Remission
  Time frame: 3, 6 and 12 months.
  Number of participants achieving a molecular remission after starting valproic acid as evidenced by disappearance of T-cell clonality as measured by gene rearrangement studies using multiplex PCR

Sponsor's own description

RATIONALE: Human T-cell lymphotropic virus type 1 (HTLV-1) can cause cancer. Zidovudine is an antiviral drug that acts against the human T-cell lymphotropic virus type 1. Giving zidovudine, interferon alfa-2b, and PEG-interferon alfa-2b together may stimulate the immune system and slow down or keep the cancer cell from growing.

PURPOSE: This clinical trial is studying how well giving zidovudine together with interferon alfa-2b and PEG-interferon alfa-2b works in treating patients with human T-cell lymphotropic virus type 1-associated adult T-cell leukemia/lymphoma.

Publications & conference data

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

1. New drugs are not enough‑drug repositioning in oncology: An update.
   Armando RG, Mengual Gómez DL, Gomez DE. · · 2020 · cited 72× · PMID 32124955 · DOI 10.3892/ijo.2020.4966
2. Trial Watch: Immunostimulatory cytokines.
   Vacchelli E, Galluzzi L, Eggermont A, Galon J, et al · · 2012 · cited 70× · PMID 22754768 · DOI 10.4161/onci.20459
3. A Review of New Findings in Adult T-cell Leukemia-Lymphoma: A Focus on Current and Emerging Treatment Strategies.
   Hermine O, Ramos JC, Tobinai K. · · 2018 · cited 61× · PMID 29411267 · DOI 10.1007/s12325-018-0658-4
4. Exploring the Drug Repurposing Versatility of Valproic Acid as a Multifunctional Regulator of Innate and Adaptive Immune Cells.
   Soria-Castro R, Schcolnik-Cabrera A, Rodríguez-López G, Campillo-Navarro M, et al · · 2019 · cited 43× · PMID 31001564 · DOI 10.1155/2019/9678098
5. Metabolic reprogramming in cancer and senescence.
   Zhang Y, Tang J, Jiang C, Yi H, et al · · 2025 · cited 13× · PMID 40046406 · DOI 10.1002/mco2.70055