ClinicalTrials.gg
Sign In
CompletedNCT00355407Updated Mar 13, 2009

Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation

An interventional study of Darbepoetin alfa in Hematologic Malignancies, sponsored by Dana-Farber Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-03-13.

Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to find out if Darbepoetin alfa is effective in treating low red blood cell levels after allogeneic stem cell transplant. Darbepoetin alfa has been shown to help raise red blood cell levels without blood transfusions.

Read the detailed description
  • Participants will receive Darbepoetin alfa through an injection under the skin, about 28-35 days after their allogeneic stem cell transplant. They will continue to receive the study drug once every three weeks for a maximum of four doses.
  • Blood tests will be performed at weeks 3, 6, 9 and 12. The blood tests done at week three will check to make sure the participant has enough iron in their system. If not, they will need to take an iron supplement. Participants will also take a folate supplement to help cell growth and reproduction.
02

Conditions studied

  • Hematologic Malignancies

Keywords

  • Aranesp
  • allogeneic stem cell transplant
03

In context

Hematologic Neoplasms

1,494 studies on the registry are indexed under Hematologic Neoplasms; 438 are open to participants now.

This study's enrollment of 31 is below the median of 45 across 1,090 interventional studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 832 studies on the registry; 122 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Browse Dana-Farber Cancer Institute studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Hematologic malignancies undergoing ablative allogeneic stem cell transplantation for any indication
  • 18 years of age or older
  • Hgb of less than 10 g/dL at the time of initiation therapy

Exclusion criteria

Exclusion Criteria:

  • Known hypersensitivity reaction to darbepoetin alfa or any of its components
  • Transfusion of packed red blood cells within 3 days of initiation of treatment with darbepoetin alfa
  • Any history of grade III or IV GVHD
  • Use of any erythropoietic growth factor since transplantation
  • Uncontrolled hypertension
  • History of seizure
  • Baseline creatinine greater than 2
  • Dialysis dependence at the time of enrollment
  • Hemolytic uremic syndrome
  • Active GI bleeding
  • Concurrent autoimmune hemolytic anemia
  • Concurrent unstable angina
  • History of congenital hypercoagulable state or previous venous or arterial thrombosis
  • Relapsed disease prior to the initiation of study treatment
  • History of renal cell carcinoma
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants

Interventions

06

What researchers measure

Primary outcomes

  1. Evaluate the percentage of patients achieving a target hemoglobin of 11 g/dL or greater by day 100 following allogeneic stem cell transplantation.

Secondary outcomes

  1. Evaluate the percentage of patients achieving a greater than 1 g/dL hemoglobin increase between days 30 and 100 after allogeneic stem cell transplantation

  2. record transfusion requirements between days 30 and 100 in patients undergoing darbepoetin alfa administration following allogeneic stem cell transplantation.

07

Study locations

1 site
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2006, a primary completion of Aug 2007 and a completion of Aug 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 19, 2006
First posted
Jul 21, 2006
Start
Jun 2006
Primary completionActual
Aug 2007
CompletionActual
Aug 2007
Last update
Mar 13, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 13, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00355407
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
Amgen, Brigham and Women's Hospital
First posted
Jul 21, 2006
Start date
Jun 2006
Primary completion
Aug 2007
Completion
Aug 2007
Last update
Mar 13, 2009

Study contacts

Eric Jacobsen, MD
principal investigator · Dana-Farber Cancer Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Darbepoetin alfa

Other studies in this condition

Hematologic Neoplasms →

Other studies from this sponsor

Dana-Farber Cancer Institute →

Start the discussion