NCT03010579

Brief Summary

This is an randomized trial to evaluate the potential benefit of erythropoietin in the treatment of anemia in patients with lymphoma after autologous hematopoietic stem cell transplantation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 5, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

December 29, 2016

Last Update Submit

January 3, 2017

Conditions

AnemiaLymphomaHematopoietic Stem Cell Transplantation

Keywords

AnemiaLymphomaHematopoietic stem cell transplantationErythropoietin

Outcome Measures

Primary Outcomes (1)

  • complete hemoglobin response rate

    proportion of complete correctors (reaching hemoglobin 120 g/L in male patients, 110 g/L in female patients) before day +60 post-transplant

    from day +15 to day +60 after autologous hematopoietic stem cell transplantation

Secondary Outcomes (2)

  • proportion of participants with red blood cell transfusions

    from day +15 to day +60 after autologous hematopoietic stem cell transplantation

  • proportion of participants with deep vein thrombosis

    from day +15 to day +60 after autologous hematopoietic stem cell transplantation

Study Arms (2)

erythropoietin group

EXPERIMENTAL

For those lymphoma patients with hemoglobin level less than 100 g/L on day +15 after autologous hematopoietic stem cell transplantation, erythropoietin will be administered. If necessary,oral ferrous succinate vitamins B12 and folic acid will be administered.

Drug: erythropoietin

iron supplementation

ACTIVE COMPARATOR

If necessary，oral ferrous succinate, vitamins B12 and folic acid will be administered.

Drug: iron supplementation

Interventions

erythropoietinDRUG

Erythropoietin will be administered subcutaneously (s.c.) at the dose of 10 000 IU, three times a week. If necessary,oral ferrous succinate vitamins B12 and folic acid will be administered.

Also known as: Erythropoiesis-Stimulating Agent
erythropoietin group
iron supplementationDRUG

If necessary, oral ferrous succinate, vitamins B12 and folic acid will be administered.

Also known as: ferrous succinate
iron supplementation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • confirmed lymphoma
  • first autologous hematopoietic stem cell transplantation
  • hemoglobin level less than 100 g/L on day +15 post-transplant
  • written informed consent given by patient or his/her guardian if of minor age.

You may not qualify if:

  • HIV positive
  • Known allergy to recombinant human erythropoietin
  • Uncontrolled infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

AnemiaLymphoma

Interventions

ErythropoietinHematinicsferrous succinate

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsHematologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Lymphoma Department

Study Record Dates

First Submitted

December 29, 2016

First Posted

January 5, 2017

Study Start

October 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

January 5, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)