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Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome

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Trial Information


Inclusion Criteria:



- Age >= 18 years 2. Patients with haematological malignancies receiving neutropenia (<
0.5 x 109/L) inducing chemotherapy (+/- TBI) requiring hospitalisation.

3. Negative pregnancy test if the patient is of childbearing potential 4. Informed consent

Exclusion Criteria:

- . Previous treatment with growth hormone 2.Unstable psychiatric conditions 3.
Uncontrolled endocrine disorders 4.Chronic severe liver disease: AST or ALT>3x upper
limit of normal range 5. Chronic severe renal disease: creatinine>150 µM or repeated
positive test for haematuria or proteinuria 6. Severe congestive heart failure 7.
Aortic stenosis associated with clinical symptoms eg syncope of angina pectoris 8.
Hypertrophic cardiomyopathy 9. Uncontrolled hypertension (diastolic blood-pressure >
105 mm Hg) 10. Diabetes mellitus that is not well controlled with
insulin/antidiabetic drugs 11. Severe respiratory disease 12. Known or suspected
allergy to growth hormone or any of its constituents 13. History of drug or alcohol
abuse within two years prior to study enrolment 14. Exposure to another
investigational medication or device currently or within three months prior to
enrolment.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind

Principal Investigator

Ray Powles, FRCP, FRCPath

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust

Authority:

United Kingdom: National Health Service

Study ID:

2128

NCT ID:

NCT00300664

Start Date:

July 2002

Completion Date:

April 2005

Related Keywords:

  • Multiple Myeloma
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia

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