Erythropoietin in the Treatment of Anemia After Autologous Hematopoietic Stem Cell Transplantation

NCT ID: NCT03010579

Last Updated: 2017-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Lymphoma patients with anemia on day +15 post-transplant will be randomized to erythropoietin group or control group. Potential benefit of erythropoietin will be evaluatedon day +60 post-transplant.

Conditions

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Anemia Lymphoma Hematopoietic Stem Cell Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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erythropoietin group

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.

Group Type EXPERIMENTAL

erythropoietin

Intervention Type DRUG

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.

iron supplementation

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

Group Type ACTIVE_COMPARATOR

iron supplementation

Intervention Type DRUG

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

Interventions

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erythropoietin

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.

Intervention Type DRUG

iron supplementation

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

Intervention Type DRUG

Other Intervention Names

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Erythropoiesis-Stimulating Agent ferrous succinate

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* HIV positive
* Known allergy to recombinant human erythropoietin
* Uncontrolled infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Jun Zhu

Chairman of Lymphoma Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Wei Ping Liu

Role: primary

Xiao Pei Wang

Role: backup

Other Identifiers

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PKU-2016KT64

Identifier Type: -

Identifier Source: org_study_id

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